External Quality Manager

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.