Senior Manager (m/f/x) Medical Affairs QA

Daiichi Sankyo Europe GmbH; München; Vor Ort; EUR 85.000 - 110.000; Vollzeit

Zusammenfassung

A global pharmaceutical leader seeks a Senior Manager Medical Affairs QA in Munich to ensure compliance with quality standards across programs. The role requires leadership in quality execution, oversight of clinical trials, and strategic collaboration with diverse teams. Candidates must have extensive experience in the industry and a strong background in regulatory compliance.

Leistungen

Work-Life-Balance

Growth and Development

Health and Wellbeing Support

Qualifikationen

• 7+ years pharmaceutical experience in clinical development in a regulated environment.
• Profound knowledge of global drug development and ICH-GCP.
• Excellent communication and problem-solving skills.

Aufgaben

• Drive end-to-end quality execution across Medical Affairs programs.
• Lead the development and execution of Corrective and Preventive Actions (CAPAs).
• Facilitate regulatory inspection preparation and management.

Kenntnisse

Leadership

Project Management

Quality Management

Regulatory Compliance

Interpersonal Skills

Ausbildung

Bachelor’s degree in Life Sciences, Nursing, Pharmacy

Master’s degree or other advanced degrees

Jobbeschreibung

Senior Manager (m/f/x) Medical Affairs QA

Join to apply for the Senior Manager (m/f/x) Medical Affairs QA role at Daiichi Sankyo Europe GmbH

Senior Manager (m/f/x) Medical Affairs QA

1 day ago Be among the first 25 applicants

Join to apply for the Senior Manager (m/f/x) Medical Affairs QA role at Daiichi Sankyo Europe GmbH

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our Global QA Team we are seeking highly qualified candidates to fill the position

Senior Manager (m/f/x) Medical Affairs QA

Purpose of the function

The Senior Manager (m/f/x) Medical Affairs QA will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a quality-driven culture within Medical Affairs. The role will involve providing oversight on strategic initiatives in close collaboration with Medical Affairs stakeholders, ensuring the highest ethical standards and quality in interventional, non-interventional, investigator-initiated trials, and managed access programs. This position will report to the Head of Medical Affairs QA.The Senior Manager will lead the review of quality and compliance topics, including Key Quality Indicators (KQIs) at Quality Governance Meetings. In close alignment with DS QA teams (DSJ, DSI, DSE, DSBR), they will proactively identify risks and opportunities for continuous improvement. This role will drive end-to-end quality execution across programs, ensuring adherence to GCP, GPV, Data Protection, and local regulatory requirements in the planning and execution of Interventional, Non-interventional, Managed Access Programs, and Investigator-Initiated Studies.The role will involve collaborating with GxP Quality representatives, serving as the primary QA point of contact for all Medical Affairs programs. The Senior Manager will support quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use or Managed Access Programs, and Investigator-Initiated Studies. This includes timely escalation of issues, oversight of deviations/incidents and investigations, third-party/vendor oversight, and liaising to support audits and inspections as applicable. The Associate Director will provide leadership in developing and executing Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and appropriate escalation of critical issues.In this role, the Senior Manager will facilitate regulatory inspection preparation, management, and follow-up in close collaboration with cross-functional teams. They will support local inspections by providing necessary systems and process support and partner with QMS QA to ensure the consistent implementation of all applicable Quality Standards within Medical Affairs. Additionally, they will identify continuous improvement initiatives for quality and compliance areas within Medical Affairs.The Senior Manager will identify opportunities to continuously improve quality and compliance with regulations, company standards, policies, and procedures through partnerships with stakeholders and QA functions. They will lead the flow of lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics. This role will provide expert interpretation of regulations, company standards, guidelines, policies, and procedures to personnel, particularly for assigned programs and continuous improvement projects. The Senior Manager will champion, develop, and drive the implementation of program-specific quality plans to ensure proactive management of quality 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 Interventional, Non-interventional, Managed Access Programs, and Investigator-Initiated Studies. Provide comprehensive quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use Programs, Managed Access Programs, and Investigator-Initiated 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 Improvement:

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 Inspection 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

Education

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy or Medicines required
• Master’s degree or other advanced degrees preferred

Experience:

• 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
• Demonstrated experience of successfully supporting projects of high impact
• Demonstrated agility in a global/matrix environment
• Strong interpersonal skills with demonstrated ability to build collaborative relationships
• Thorough and extensive knowledge of ICH-GCP including FDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s and current industry practice
• Excellent verbal and written communication skills and computer skills.
• Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation
• Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas
• Flexibility to react to changing priorities in a dynamic business environment
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world High

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

What we offer

• Work-Life-Balance
• Growth and Development
• Health and Wellbeing Support

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Daiichi Sankyo Europe GmbH by 2x

Get notified about new Senior Manager jobs in Munich, Bavaria, Germany.

Senior Customer Operations Manager (m/f/d)

Senior Sales Manager Payment & Identity (m/w/d)

Oberhaching, Bavaria, Germany 1 month ago

(Senior-) Manager Financial Services - Operational Excellence (w/m/d)

Senior Manager Strategic Business Partnering (m/w/d)

Senior Manager Commercial Strategy – Healthcare & Life Sciences (m/f/d)

Senior Manager Strategic Business Partnering (m/f/d)

Senior / Lead Solution Manager for GenAI in Banking

Senior Manager Product Marketing Industrial and IoT (m/f/d) - Qualcomm Germany

Senior Program Manager Consumer Perception, Insights & Innovation DE

Senior Manager Business Planning (m/f/d)

(Senior) Manager Operations Excellence & Quality Transformation (m/w/d)

Senior Manager Customer & Product Insights (m/f/d)

Martinsried, Bavaria, Germany 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.