Accounts Payable / Receivable Senior Executive Mumbai, India (hybrid: 3 days office, 2 days home) Salary: Competitive + Benefits + Bonus If you are an agile, committed, responsible and proactive accounting professional with a passion for accounts payable and receivable operations, then we want to hear from you! Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands, and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Spain, Germany, China, Switzerland, U.A.E., India, Singapore, Italy, and South Korea. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. About the role: As Account Payable / Receivable Executive, you will be part of our dynamic team based in Mumbai, India. You will have strong experience in accounts payable / receivable functions and be able to demonstrate your aptitude for managing invoice processing, remediation, supplier / customer reconciliation, and payment processing / receipt. Reporting to the Accounts Manager, this role requires proactive engagement, exceptional teamwork skills, and the ability to thrive in a fast-paced environment. Main responsibilities & duties: Invoice Management: Efficiently handle the accounts payable / receivable inbox, ensuring timely processing of sales / purchase invoices and accurate data entry into the accounting system. Invoice Processing: Execute end-to-end invoice processing activities, including validation, coding, and approval workflows, while adhering to established policies and procedures. Sales Invoice Processing: Process sales invoices accurately and in a timely manner. Ensure compliance with company policies and accounting standards. Invoice Remediation: Identify and resolve discrepancies or issues with sales / purchase invoices promptly, collaborating with internal stakeholders and vendors / customers to ensure timely resolution. Supplier /Customer Reconciliation: Conduct periodic reconciliation of supplier / customer accounts to ensure accuracy and completeness of transactions, proactively resolving any discrepancies. Payment Processing: Assist in the preparation and processing of payments to vendors, ensuring adherence to payment terms and compliance with regulatory requirements. Payment Applications: Apply payments accurately to customer accounts. Maintain updated records of payment transactions and reconciliations. Team Collaboration: Work closely with cross-functional teams, including Finance, Procurement, and Operations, to streamline accounts processes and drive efficiency improvements. Project Involvement: Participate in transformational finance projects aimed at enhancing systems, processes, and controls within the accounts function. About you: Candidates with accounts payable / receivable experience within a large-scale or multinational pharmaceutical company, retail or manufacturing business, or similar commercial background are likely to have the skills required to be successful in this role. We are also looking for: Bachelor's degree in Accounting, Finance, or a related field Relevant experience in accounts payable / receivable operations, preferably in a multinational or large-scale organisation Proficiency in accounting software, SAP and VIM preferable and MS Office suite, with advanced Excel skills Strong analytical and problem-solving abilities, with keen attention to detail and able to work on own initiative to be responsible for ledgers Excellent communication and interpersonal skills, with the ability to collaborate effectively in a team-oriented environment Proactive mindset with a commitment to delivering high-quality results under tight deadlines Flexibility to adapt to changing priorities and willingness to take on new challenges and responsibilities Prior experience working on finance transformation projects is a plus What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. Please note that whilst this is a hybrid role, you may be required to attend the office five days per week for the first six months for training purposes. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible. Show more Show less
Associate Manager, Pharmacovigilance Mumbai, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and detail-oriented pharmacovigilance professional with 8+ years of total PV experience, including a minimum of 4-5 years in authoring aggregate safety reports and Risk Management Plans (RMPs) and have additional experience overseeing ICSR compliance activities at both local and global levels, then we would love to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. Main responsibilities & duties: Prepare and author aggregate safety reports and regulatory documents, including PADERs, Summary Evaluation Reports (SERs), and Serious Adverse Reaction (SAR) reports Prepare and author Risk Management Plans (RMPs) Provide strategic oversight and operational management of SDEAs, including authoring, reviewing, and ensuring ongoing compliance Ensure compliance with ICSR submission timelines and partner obligations Develop and maintain internal processes to support core pharmacovigilance activities Support and participate in pharmacovigilance audits and regulatory inspections Contribute to product labelling activities based on safety data and evolving benefit-risk profiles Monitor and assess regulatory intelligence updates and implement necessary changes to PV systems and practices Assist with pharmacovigilance risk assessments and due diligence activities for new products or partnerships Develop, track, and report key performance indicators (KPIs) to senior leadership for informed decision-making Collaborate cross-functionally with internal leadership teams to ensure PV oversight aligns with broader business goals About you: Candidates with progressive pharmacovigilance experience, specifically in authoring aggregate reports, RMPs, as well as management and oversight of SDEAs and ICSR compliance activities, should have the skills and experience required for the role. We are also looking for: Bachelor's degree in Pharmacy (Master's degree desirable) 8+ years of experience in pharmacovigilance with minimum 4-5 years of experience in authoring aggregate reports/RMPs is essential. Experience in working with core pharmaceutical companies desirable Strong knowledge of PV regulations at local and global level Experience in management of SDEAs Experience in ICSR review and compliance monitoring Organised and inquisitive, with problem solving skills Solid time management skills, the ability to multitask and see the big picture Strong technical skills Adaptability and resilience What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
Manager, Medical Content Review & Regulatory Compliance Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed and detail-oriented pharmacist or physician, with experience in medical review from a healthcare compliance perspective, then we want to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. About the role: As Manager, Medical Content Review & Regulatory Compliance, you will manage the medical reviewer function for Pharmanovia, including all Medical Legal Regulatory (MLR) management together with medical and regulatory review management tasks. This is a broad ranging role requiring responsible implementation of MLR policies, systems and procedures within the global medical team. You will be a trained pharmacist or physician with experience in the medical review of promotional and non-promotional materials from a healthcare compliance perspective. Final signatory and certification are relevant for this role, from an EFPIA and ABPI perspective, but not essential. Reporting into the Medical Affairs department, you will be working as an individual contributor and act as a key member of the wider Scientific Affairs team. The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment. Main responsibilities & duties: Performing full medical (and regulatory, i.e. against SmPC) review of promotional and non-promotional materials as well as HCP/HCO events including fair market value (FMV) assessment for disclosures (ToV) Training colleagues and third parties on MLR related SOPs and processes Coordinating MLR review, maintaining related SOPs (and auditing program to ensure compliance) Management of potential 3rd Party Material review partner(s) Implementing an internal pre-approval/reporting procedure Final sign-off and certification (or willing to do so in the future) Establishing and developing controls and documentation requirements Collaborating with Marketing and other relevant departments to create adequate Q&As / guidance for products and materials, managing central MLR database Disease area and competitors' knowledge, materials review from competitors Datamining of MLR database to support various internal departments and share relevant insights Maintaining a clear understanding and oversight of different MLR processes and partners within Pharmanovia's operations Being a credible MLR expert in the EFPIA and ABPI environments Engaging with external stakeholders to ensure a good understanding of the external environment and different stakeholder groups e.g. Health Authorities, External Experts, Associations, Patient groups, Payers, etc. Please note: This is not a pharmacovigilance or medical transcription role. We're looking for a medically qualified professional-such as a pharmacist or physician-with proven experience in Medical, Legal, and Regulatory (MLR) review of both promotional and non-promotional materials. The ideal candidate will have worked within a global Medical Affairs or Compliance environment and is confident navigating cross-functional review processes. About you: Candidates qualified as a pharmacist or physician, with experience of medical review from a healthcare compliance perspective, should have the skills and experience required for the role. We are also looking for: Pharmacy or Medical degree Final signatory (or willing to become one) desirable Strong understanding of EFPIA and/or ABPI codes of practice and willing to learn to fill any knowledge gaps Full professional proficiency in English (written and verbal) Experience in design, strategy execution and oversight of MLR process Organised, inquisitive, innovative problem solvers with the ability to perceive, understand and interpret facts quickly and precisely Solid time management skills, the ability to multitask and see the big picture Strong technical skills A resilient individual who is not afraid to challenge at all levels Data driven in decision making with the ability to analyse, focus on the key issues and communicate with clarity What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
External Quality Manager Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed and detail-oriented pharmaceutical Quality Manager, with experience in managing the Quality aspects of contract manufacturing organisations, then we want to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. About the role: As External Quality Manager, you will play a key role in overseeing the Quality aspects of external manufacturing operations including Quality Agreements, audits, deviation management, and product lifecycle support - ensuring compliance and collaboration across Pharmanovia's global supply partners. Our ideal candidate will have experience within the pharmaceutical industry handling third party manufacturing organisations with a number of following disciplines: Quality Systems, Quality Operations, QC Laboratory, Analytical or Process Validation, Manufacturing, Production or Warehouse. Main responsibilities & duties: Write, review and negotiation of Quality Agreements and to ensure key responsibilities are documented Completion of assigned Quality Technical Agreements in line with project timelines Provide effective quality oversight of the Quality aspects of several contract manufacturing organisations during project phase and transition to business-as-usual Support planning and execution of audits of third parties Quality oversight CMO Deviations, Change Controls, complaints Support timely discussion of OOS results with other Quality/Technical staff Quality support for qualification of a new CMO Leading reviews investigations in a timely manner and timely escalations to the manager/QP as required Liaise with internal and external stakeholders as required to achieve timely completion of all CAPAs relating to customer & internal audit CAPAs Ensure oversight of the product stability set up activities for products Timely completion of ad hoc and other tasks as assigned Quality support for product technology transfer To identify, review and present any quality risk associated with product and escalate to project manager and line manager. Building the relationship with affiliate companies and CMOs for the designated products from Quality point of view About you: Candidates with progressive experience in managing CMOs across several disciplines within the pharma environment should have the skills and experience required for the role. We are also looking for: Bachelor's degree in pharmaceutical sciences or equivalent, postgraduate degree or diploma is a bonus Lead Auditor Qualification (and additional Supplier Qualification is a plus) Excellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, Teams Quality software skills (Trackwise, SAP) desirable Good working knowledge of current GMP, SOPs, EU GMDP guidelines and regulations and ICH guidelines Strong QMS elements knowledge and experience (Deviations, OOS, Investigations, CAPA, change management, complaints) Experience of manufacturing solid dosage forms, liquids, creams and sterile products Experience of routinely preparing and negotiating Quality Technical Agreements Experience of facilitating OOS and Root Cause Analysis Knowledge of GDP is desirable Experience of Technology Transfer and Nitrosamine risk assessment is desirable Precise and attentive to minute details while reviewing critical due-diligence documents to escalate the manager on product quality issue Ability to work on own as well as part of team, collaboration across cross-functional environments Ability to build strong professional relationships Excellent professional English communication skills, both written and verbal What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
QMS Specialist Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed and detail-oriented Quality Specialist, with experience gained in specifically in pharmaceutical Quality Management Systems and Computerized Systems, then we want to hear from you. Join us to help improve peoples' lives and make healthcare better for everyone! Why Pharmanovia? Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines. Our core behaviours are: We act decisively but we never compromise on quality. We keep our promises and do as we say. We value our heritage and foster an entrepreneurial spirit. We reinvest in our future - in our products, our brands and our people. We give back to our communities. Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore. We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce. Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology. About the role: As QMS Specialist you will support the effective operation, maintenance, and continuous improvement of the global Quality Management System (QMS) within a complex, multi-entity, virtual pharmaceutical business. You will ensure quality compliance across all GxP activities by contributing to the design and implementation of quality systems, monitoring of quality processes, and provision of quality support and oversight across business functions. Reporting directly to the Associate Director Internal Quality System, our key expectations are a broad understanding and experience of QMS requirements, operation and compliance in a GMP and GDP environment, along with proven experience in the implementation of Computerized Systems (CS). You will act as primary contact for CS compliance and life cycle management, and be expected to bring to the role great organisation skills, good attention to detail, a proactive nature, and be a confident communicator, both within the business and with external partners. You will also be a problem solver with an inquisitive mind and an appetite to develop your technical skills. Main responsibilities & duties: Maintain and update controlled quality documents, including SOPs, policies, and templates Support and oversee deviation investigations and CAPA lifecycle management, ensuring timely closure and regulatory compliance Review and oversee change control records, supporting impact assessments and coordinating stakeholder input reviews Ensure that the GxP computerized systems meet the regulatory requirements (Annex 11) - a key deliverable of the role Act as system administrator for TrackWise Digital EQMS software to support the effective operation of the QMS Administrate and monitor the GxP training system, maintaining training compliance and records Participate in internal audits and support audit readiness for external audits and regulatory inspections Coordinate document and data archiving processes in alignment with data integrity and retention standards Compile and analyse quality metrics for reporting in QA and Management Reviews Assist with cross-functional quality risk assessments Contribute to continuous improvement initiatives and support harmonisation efforts across affiliates Liaise with cross-functional teams (Regulatory, PV, Supply Chain, Medical Affairs) to support QMS compliance Maintain awareness of relevant GxP requirements (e.g., EU GMP, GDP, ICH, MHRA, Swissmedic) and emerging regulatory expectations Coordinate and maintain oversight of Product Quality Complaint investigations Other QA related activities as required to support the department or business About you: Candidates with at least two years' experience in a GxP-regulated Quality role, with proven experience in QMS elements and CS implementation within a pharmaceutical MAH or virtual company, should have the skills and experience required for the role. We are also looking for: Bachelor's degree in life sciences or related degree, or equivalent relevant experience Proven experience in Computerized System implementation Practical experience with QMS elements: document control, deviations/CAPA, change control, training, complaints, audit support Familiarity with EU/UK GMP, GDP, Annex 11, and ideally some exposure to Swiss or ICH frameworks Experience in a multi-entity or virtual operating model Exposure to TrackWise, Veeva, or other electronic QMS platforms Experience supporting inspections (MHRA, EMA, Swissmedic, etc.) Involvement in quality metrics and management review reporting Strong attention to detail and organisation skills Able to work independently and manage competing priorities remotely Problem-solving mindset with ability to interpret regulations pragmatically Excellent verbal and written communication Excellent IT skills across all MS packages including Excel, Word, PowerPoint, Outlook, Teams Team player, comfortable in a global, cross-functional environment What we offer: We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working. By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.
As a Senior Executive Financial Reporting at Pharmanovia, you will play a crucial role in managing the general ledger and ensuring accurate and timely recording of financial transactions. Reporting to the Senior Manager of Management Accounts, your responsibilities will include posting manual journals, conducting balance sheet reconciliations, categorizing costs effectively, and actively participating in finance projects to enhance efficiency. Your expertise in management accounting within a multinational pharmaceutical or manufacturing environment will be essential to succeed in this dynamic role. Pharmanovia is a fast-growing international pharmaceutical company with a mission to improve patient health globally through the revitalization of niche medicines. Our core values of decisiveness, integrity, heritage preservation, and community engagement drive our commitment to quality and innovation. With over 300 employees from 29 nationalities, Pharmanovia fosters a supportive culture that encourages entrepreneurship and collaboration. Key Responsibilities: - Manage the general ledger and ensure accurate financial transaction recording - Conduct monthly balance sheet reconciliations for data accuracy - Categorize costs effectively to aid budgeting and decision-making processes - Participate in finance projects to enhance operational efficiency - Collaborate with cross-functional teams to provide financial insights for decision-making - Assist in preparing financial reports, variance analysis, and management reporting - Ensure compliance with regulatory requirements and internal controls - Identify areas for process improvement and implement best practices - Support the Senior Manager in ad-hoc tasks and projects as needed Qualifications and Skills: - Bachelor's degree in Accounting, Finance, or related field - Professional certification such as CA, CMA, or equivalent preferred - Proven experience in management accounting, preferably in a multinational environment - Strong technical knowledge of accounting principles and practices - Proficiency in ERP systems (SAP, Oracle, etc.) and advanced MS Excel skills - Excellent analytical and problem-solving abilities - Effective communication and interpersonal skills - Track record of proactive teamwork and engagement - Experience in finance transformation projects desirable - Adaptability to change and commitment to continuous improvement - High level of integrity and professionalism Please note that this hybrid role in Mumbai requires attendance at the office five days a week for the first six months due to training requirements. Pharmanovia offers a competitive salary, bonus, holiday, health & wellbeing program, employee recognition awards, pension scheme, and hybrid working opportunities. Join us in our mission to improve lives and healthcare globally by applying for this exciting role today.,
As a QMS Specialist at Pharmanovia, you will play a crucial role in supporting the effective operation, maintenance, and continuous improvement of the global Quality Management System (QMS). Your responsibilities will include ensuring quality compliance across all GxP activities, contributing to the design and implementation of quality systems, monitoring quality processes, and providing oversight across business functions. You will report directly to the Associate Director Internal Quality System and be expected to have a broad understanding and experience of QMS requirements, operation, and compliance in a GMP and GDP environment. Key Responsibilities: - Maintain and update controlled quality documents such as SOPs, policies, and templates - Support and oversee deviation investigations and CAPA lifecycle management - Review and oversee change control records, ensuring regulatory compliance - Act as the primary contact for Computerized Systems (CS) compliance and life cycle management - Administer TrackWise Digital EQMS software to support the effective operation of the QMS - Monitor the GxP training system and maintain training compliance and records - Participate in internal audits and support audit readiness for external audits - Coordinate document and data archiving processes in alignment with data integrity standards - Compile and analyze quality metrics for reporting in QA and Management Reviews - Assist with cross-functional quality risk assessments - Contribute to continuous improvement initiatives and support harmonization efforts across affiliates - Liaise with cross-functional teams to ensure QMS compliance - Maintain awareness of relevant GxP requirements and emerging regulatory expectations - Coordinate and maintain oversight of Product Quality Complaint investigations - Perform other QA related activities as required to support the department or business Qualifications Required: - Bachelor's degree in life sciences or related field, or equivalent relevant experience - At least two years of experience in a GxP-regulated Quality role - Proven experience in Computerized System implementation - Practical experience with QMS elements such as document control, deviations/CAPA, change control, training, complaints, and audit support - Familiarity with EU/UK GMP, GDP, Annex 11, and exposure to Swiss or ICH frameworks - Experience in a multi-entity or virtual operating model - Exposure to TrackWise, Veeva, or other electronic QMS platforms - Experience supporting inspections from regulatory bodies - Strong attention to detail, organizational skills, and ability to work independently - Problem-solving mindset and ability to interpret regulations pragmatically - Excellent verbal and written communication skills - Proficient in IT skills across MS packages including Excel, Word, PowerPoint, Outlook, and Teams Join Pharmanovia to be part of a dynamic, fast-growing international pharmaceutical company that aims to improve patient health globally through the revitalization of niche, tried-and-trusted medicines. As a valued team member, you will have the opportunity to contribute to the company's mission while enjoying a competitive salary, bonus, holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working environment.,