Role Overview: Sandoz is seeking a Project Quality Management Specialist to oversee quality and validation efforts in BioPharma IT projects. In this role, you will ensure compliance with regulatory standards, drive process improvement, and provide quality support to project teams. Key Responsibilities: - Plan, execute, and assess quality activities aligned with ITQM objectives and service descriptions. - Ensure projects adhere to security and regulatory compliance requirements. - Coordinate and oversee validation efforts to meet quality standards. - Develop and implement quality/validation strategies, deliverables, and procedures. - Review and approve system documentation for completeness and stakeholder alignment. - Conduct compliance reviews against corporate and regulatory policies such as GxP and CSV. - Guide project teams on quality perspectives, mediate conflicts, and advocate for quality approaches. - Train and coach teams on quality standards and lifecycle processes to foster continuous improvement. Qualifications Required: - Bachelor's degree in computer science, Information Systems, Mathematics, Informatics, or a related field. - 3-6 years of experience in BioPharma IT Quality & Compliance departments. - Hands-on experience managing quality in international and cross-functional IT projects. - Expert knowledge of GxP, CSV, GAMP, and pharmaceutical validation requirements. - Strong understanding of IT system lifecycle phases (requirements, design, testing, deployment). - Project management skills to plan and monitor quality and security tasks. - Familiarity with Agile methodologies; DevSecOps and Six Sigma are advantageous. - Effective communication and stakeholder engagement skills across technical and non-technical audiences. Additional Company Details: Sandoz is a global leader in providing sustainable Biosimilar and Generic medicines to more than 100 countries, delivering over 900 million patient treatments in 2024. The company is committed to shaping the future of healthcare by expanding development capabilities, production sites, acquisitions, and partnerships to increase patient access to affordable, high-quality medicines sustainably. Sandoz fosters an open, collaborative culture that values diversity and personal growth, offering impactful, flexible-hybrid careers in a growth-oriented work environment. Join Sandoz to be a part of a purpose-driven organization and contribute to the advancement of global healthcare. Role Overview: Sandoz is seeking a Project Quality Management Specialist to oversee quality and validation efforts in BioPharma IT projects. In this role, you will ensure compliance with regulatory standards, drive process improvement, and provide quality support to project teams. Key Responsibilities: - Plan, execute, and assess quality activities aligned with ITQM objectives and service descriptions. - Ensure projects adhere to security and regulatory compliance requirements. - Coordinate and oversee validation efforts to meet quality standards. - Develop and implement quality/validation strategies, deliverables, and procedures. - Review and approve system documentation for completeness and stakeholder alignment. - Conduct compliance reviews against corporate and regulatory policies such as GxP and CSV. - Guide project teams on quality perspectives, mediate conflicts, and advocate for quality approaches. - Train and coach teams on quality standards and lifecycle processes to foster continuous improvement. Qualifications Required: - Bachelor's degree in computer science, Information Systems, Mathematics, Informatics, or a related field. - 3-6 years of experience in BioPharma IT Quality & Compliance departments. - Hands-on experience managing quality in international and cross-functional IT projects. - Expert knowledge of GxP, CSV, GAMP, and pharmaceutical validation requirements. - Strong understanding of IT system lifecycle phases (requirements, design, testing, deployment). - Project management skills to plan and monitor quality and security tasks. - Familiarity with Agile methodologies; DevSecOps and Six Sigma are advantageous. - Effective communication and stakeholder engagement skills across technical and non-technical audiences. Additional Company Details: Sandoz is a global leader in providing sustainable Biosimilar and Generic medicines to more than 100 countries, delivering over 900 million patient treatments in 2024. The company is committed to shaping the future of healthcare by expanding development capabilities, production sites, acquisitions, and partnerships to increase patient access to affordable, high-quality medicines sustainably. Sandoz fosters an open, collaborative culture that values diversity and personal growth, offering impactful, flexible-hybrid careers in a growth-oriented work environment. Join Sandoz to be a part of a purpose-driven organization and contribute to the advancement of global healthcare.
Role Overview: Sandoz is looking for a Specialist to join their team in project delivery and operations within Clinical Development. As a Specialist, you will collaborate with business stakeholders and IT partners to analyze demands, evaluate solutions, and ensure successful project delivery. Additionally, you will be responsible for overseeing the operations of global and local systems and applications to maintain stability, compliance, and performance. Key Responsibilities: - Provide technical support for Clinical Development applications such as Entimo, R, SAS, LabVantage, Spotfire, and SharePoint. - Analyze and resolve technical issues promptly. - Collaborate with development teams to enhance application performance. - Assist in release management, system upgrades, and enhancements. - Develop troubleshooting and maintenance documentation. - Monitor application performance to optimize user experience. - Create training materials and user manuals, delivering training to end-users. - Ensure compliance with GxP, 21 CFR Part 11, and Annex-11 standards. - Deliver services securely, on time, and within budget for designated areas. - Ensure platforms and solutions meet business requirements and provide value. Qualification Required: Essential Requirements: - Minimum of 6 years of experience in maintaining Clinical Development applications. - Familiarity with the life sciences industry, particularly clinical development. - Demonstrated ability to establish trust-based relationships with stakeholders. - Experience engaging with senior management and business teams. - Proficiency in GxP systems and related tools (ALM, SNOW). - Strong technological background with coding principles understanding. - Business acumen and commercial awareness. - Proficiency in demand planning, IT infrastructure, and technology utilization. - Ability to analyze stakeholder needs and collaborate globally. - Fluency in written and spoken English. Desirable Requirements: - Experience in regulated environments and compliance frameworks. - Knowledge of IT applications and tools pertinent to clinical development. Additional Details of the Company: Sandoz is a global leader and provider of sustainable Biosimilar and Generic medicines, committed to shaping the future of healthcare. Their dedication to expanding access to high-quality medicines drives their transformative initiatives and growth opportunities. With a collaborative and inclusive work culture, Sandoz offers flexible working arrangements, global learning programs, and impactful projects in clinical technology. Join Sandoz to contribute to the meaningful advancements in the pharmaceutical industry! (Note: Skills Desired - Budget Management, Business Acumen, Performance Management, Planning, Risk Management, Service Delivery Management, Stakeholder Management, Waterfall Project Management) Role Overview: Sandoz is looking for a Specialist to join their team in project delivery and operations within Clinical Development. As a Specialist, you will collaborate with business stakeholders and IT partners to analyze demands, evaluate solutions, and ensure successful project delivery. Additionally, you will be responsible for overseeing the operations of global and local systems and applications to maintain stability, compliance, and performance. Key Responsibilities: - Provide technical support for Clinical Development applications such as Entimo, R, SAS, LabVantage, Spotfire, and SharePoint. - Analyze and resolve technical issues promptly. - Collaborate with development teams to enhance application performance. - Assist in release management, system upgrades, and enhancements. - Develop troubleshooting and maintenance documentation. - Monitor application performance to optimize user experience. - Create training materials and user manuals, delivering training to end-users. - Ensure compliance with GxP, 21 CFR Part 11, and Annex-11 standards. - Deliver services securely, on time, and within budget for designated areas. - Ensure platforms and solutions meet business requirements and provide value. Qualification Required: Essential Requirements: - Minimum of 6 years of experience in maintaining Clinical Development applications. - Familiarity with the life sciences industry, particularly clinical development. - Demonstrated ability to establish trust-based relationships with stakeholders. - Experience engaging with senior management and business teams. - Proficiency in GxP systems and related tools (ALM, SNOW). - Strong technological background with coding principles understanding. - Business acumen and commercial awareness. - Proficiency in demand planning, IT infrastructure, and technology utilization. - Ability to analyze stakeholder needs and collaborate globally. - Fluency in written and spoken English. Desirable Requirements: - Experience in regulated environments and compliance frameworks. - Knowledge of IT applications and tools pertinent to clinical development. Additional D
Role Overview: Sandoz is currently undergoing a transformative phase as a global leader in providing sustainable Biosimilar and Generic medicines. As the company ventures on this new path, there are unique opportunities available for personal and professional growth. Join Sandoz in shaping the future! Key Responsibilities: - Design and maintain enterprise-wide technology frameworks such as ITIL, Agile, SAFe, DevOps, TOGAF. - Ensure alignment of frameworks with organizational goals, compliance standards, and industry best practices. - Develop governance models for consistent application of frameworks across teams. - Evolve the Sandoz Technology Operating Model in line with strategic goals. - Define methodologies for project and portfolio management, architecture, and innovation. - Provide training, toolkits, and guidance for effective implementation of methodologies. - Curate and manage a repository of frameworks, templates, and reference materials. - Collaborate with cross-functional teams and serve as a trusted advisor to senior leaders. Qualifications Required: - Bachelor's or master's degree in information technology, Engineering, Business, or related field. - Minimum 5 years of experience in technology governance, enterprise architecture, or IT operations. - Experience with GxP standards and compliance. - Expertise in ITIL, Prince2, PMP, Agile, and other industry-standard methodologies. - Experience in supporting organizational change and transformation initiatives. - Strategic thinker with a proactive approach to methodology and process design. - Strong analytical, communication, and stakeholder management skills. - Ability to work in a fast-paced, matrixed environment with global teams. - Comfortable navigating ambiguity and driving clarity in complex environments. Additional Company Details: Sandoz, a leader in the Generic and Biosimilar medicines sector, provided over 900 million patient treatments across 100+ countries in 2024. The company's ambition is to continue shaping the future of healthcare by providing access to low-cost, high-quality medicines sustainably. Sandoz fosters a collaborative, inclusive, and growth-oriented work culture, offering competitive compensation, benefits, flexible working arrangements, and opportunities for continuous learning and professional development. Note: Desirable skills include Budget Management, Business Acumen, Performance Management, Planning, Risk Management, Service Delivery Management, Stakeholder Management, and Waterfall Project Management. Role Overview: Sandoz is currently undergoing a transformative phase as a global leader in providing sustainable Biosimilar and Generic medicines. As the company ventures on this new path, there are unique opportunities available for personal and professional growth. Join Sandoz in shaping the future! Key Responsibilities: - Design and maintain enterprise-wide technology frameworks such as ITIL, Agile, SAFe, DevOps, TOGAF. - Ensure alignment of frameworks with organizational goals, compliance standards, and industry best practices. - Develop governance models for consistent application of frameworks across teams. - Evolve the Sandoz Technology Operating Model in line with strategic goals. - Define methodologies for project and portfolio management, architecture, and innovation. - Provide training, toolkits, and guidance for effective implementation of methodologies. - Curate and manage a repository of frameworks, templates, and reference materials. - Collaborate with cross-functional teams and serve as a trusted advisor to senior leaders. Qualifications Required: - Bachelor's or master's degree in information technology, Engineering, Business, or related field. - Minimum 5 years of experience in technology governance, enterprise architecture, or IT operations. - Experience with GxP standards and compliance. - Expertise in ITIL, Prince2, PMP, Agile, and other industry-standard methodologies. - Experience in supporting organizational change and transformation initiatives. - Strategic thinker with a proactive approach to methodology and process design. - Strong analytical, communication, and stakeholder management skills. - Ability to work in a fast-paced, matrixed environment with global teams. - Comfortable navigating ambiguity and driving clarity in complex environments. Additional Company Details: Sandoz, a leader in the Generic and Biosimilar medicines sector, provided over 900 million patient treatments across 100+ countries in 2024. The company's ambition is to continue shaping the future of healthcare by providing access to low-cost, high-quality medicines sustainably. Sandoz fosters a collaborative, inclusive, and growth-oriented work culture, offering competitive compensation, benefits, flexible working arrangements, and opportunities for continuous learning and professional development. Note: Desirable skills include Budget Management, Business Acumen, Performance Management, Planning, Risk Managemen