Associate Director, Medical Affairs QA

Daiichi Sankyo Europe

Multiple Locations, Europe

Purpose of the function

The Associate Director, 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.

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;
Strong project management skills;
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.