Purpose of the function

LOCATION: Munich, Germany

The Senior Manager, Medical Affairs QA provides leadership and strategic direction for assigned programs, ensuring the effective implementation of quality strategies and fostering a quality-driven culture within Medical Affairs. This role oversees strategic quality initiatives in close collaboration with Medical Affairs stakeholders and serves as the primary QA point of contact for all Medical Affairs programs.  Reporting to the Head of Development and Medical Affairs QA, the Senior Manager is responsible for end-to-end quality oversight across interventional and non-interventional studies, investigator-initiated studies, and managed access or compassionate use programs. This includes ensuring compliance with GCP, GPV, data protection, and applicable local regulatory requirements throughout program planning and execution.  In close alignment with Development Sciences QA teams (DSJ, DSI, DSE, DSBR) and other GxP Quality representatives, the Senior Manager proactively identifies risks, drives continuous improvement initiatives, and ensures consistent implementation of quality standards and processes.

The role includes leading the review of quality and compliance topics, including Key Quality Indicators (KQIs), at Quality Governance Meetings, and overseeing deviations, incidents, and investigations with appropriate escalation. The Senior Manager also provides oversight of third-party vendors and supports audit and inspection readiness, including preparation, management, and follow-up activities.  Additionally, the Senior Manager leads the development and execution of Corrective and Preventive Actions (CAPAs), ensuring timely closure, effectiveness, and proper escalation of critical issues. The role supports regulatory inspections and partners with QMS QA to ensure alignment and consistency in quality management systems and standards.

The Senior Manager is responsible for driving the integration of lessons learned from audits, inspections, and regulatory intelligence into ongoing improvements, as well as providing expert interpretation of regulations, company standards, and policies. They champion and implement program-specific quality plans to ensure proactive quality management across the program lifecycle.

Roles and Responsibilities

Leadership and Project Management

• Drive end-to-end quality execution across programs, ensuring compliance with GCP, GPV, Data Protection, and other local regulations throughout the planning and execution of lnterventional, Non-interventional, Managed Access Programs, and lnvestigator-lnitiated Studies.
• Provide comprehensive quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use Programs, Managed Access Programs, and lnvestigator-lnitiated Studies. This includes the timely escalation of issues, oversight of deviations/incidents and investigations, management of third-party/vendor performance, and serving as a liaison to support audits and inspections as needed.

Quality Management and Continuous lmprovement

• Provide leadership and guidance in the development and execution of Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and the appropriate escalation of critical issues.
• Collaborate with QMS QA to ensure the consistent implementation of all relevant Quality Standards within Medical Affairs and identify opportunities for continuous improvement in quality and compliance across the department.
• Continuously assess and improve quality and compliance with regulations, company standards, policies, and procedures by partnering with stakeholders and QA functions.
• Provide clear interpretation of regulations, company standards, guidelines, policies, and procedures to personnel, particularly for assigned programs and continuous improvement initiatives. Lead the development, implementation, and proactive management of program-specific quality plans to ensure high standards of quality throughout the lifecycle of each study or program.

Customer-Focused / Stakeholder Engagement

• Provide quality oversight for strategic initiatives, working closely with Medical Affairs stakeholders to ensure the highest ethical standards and quality in the execution of interventional, non-interventional, investigator-initiated trials, and managed.

Regulatory lnspection Management and Lessons Learned

• Facilitate the preparation, management, and follow-up of regulatory inspections in close collaboration with business functions, ensuring thorough support for local inspections with robust systems and process resources.
• Lead the flow of lessons learned from audits, inspections, incidents, regulatory intelligence, and process effectiveness checks, utilizing this information to drive continuous improvement through targeted actions and metric.

Education & Experience

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or Medicines
• Master's degree or other advanced degrees (Preferred)
• 7 or more years pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in regulated GCP environment required

Skills and additional Requirements

• Profound knowledge of global drug development, including extensive expertise in ICH-GCP, FDA/EU regulations, pharmacovigilance, and current industry practices
• Proven track record of successfully supporting high-impact, complex projects
• Strong project management skills with the ability to prioritize and deliver in dynamic environments
• Demonstrated ability to work effectively in global, matrix organizations, building collaborative relationships and influencing cross-functional stakeholders to drive alignment
• Excellent communication and interpersonal skills, with the ability to convey complex information clearly and effectively
• Strong problem-solving, decision-making, and conflict resolution skills
• High degree of organizational awareness, with experience navigating cross-functional teams and diverse global environments
• Adaptable and flexible, with the ability to respond to changing priorities and business needs
• Proficient in relevant computer and digital tools