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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France, Madrid, Spain, Warsaw, Masovian, Poland

Job Description:

Position Summary

The Associate Director, QA Clinical Team Lead will be a key member of the extended R&D Quality (RDQ) Clinical QA leadership. This role will provide strategic and operational leadership for a team of GCP auditors as it relates to audit execution, inspection readiness, and talent development.

Main responsibilities will include but are not limited to:

Leadership & People Management:

• Lead, coach, and develop a team of GCP auditors, ensuring high performance, engagement, and technical excellence

• Oversee audit resourcing and workload planning to support timely and compliant audit delivery

• Set and align team objectives with departmental and organizational goals and priorities

• Foster an inclusive, collaborative culture that reflects the company’s Credo and commitment to diversity and development

• Serve as delegate for the QA Clinical Functional Management Director as required

Auditing & Compliance:

• Conduct and oversee GCP and other applicable GxP audits (e.g. system/process, clinical program, vendor, local operating company, clinical investigator site audits)

• Provide expert guidance on audit scoping, planning, execution, reporting, and peer review

• Ensure consistent application of risk‑based audit methodologies, standards, and procedures

• Support development, approval, and resolution of CAPAs to ensure timely CAPA closure.

• Promote harmonization and global alignment of audit practices

• Serve as Clinical QA contact for Health Authority inspections, including inspection readiness and coordinating activities with other functions as needed

Training & Talent Development:

• Identify capability gaps and develop training strategies to support GCP/GxP compliance

• Ensure development plans are in place for direct reports and support career progression

• Contribute to training curriculum development and ensure completion of required training

• Monitor team performance metrics and auditor competencies to support current and future business needs

Expertise & Continuous Improvement:

• Maintain expert‑level knowledge of GCP/GxP regulations and global regulatory expectations

• Lead and contribute to cross‑functional and enterprise quality initiatives

• Build strong internal and external partnerships to support innovative, effective quality solutions

• Serve as a trusted advisor to business partners and represent R&D Quality with a unified quality voice

Qualifications

• A minimum of a Bachelor of Science (BSc) degree is required with a focus in science, life science or pharmaceutical science is required. An advanced degree (i.e. MSc, Ph.D, Pharm D) preferred.

• A minimum of 8 years relevant work experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP regulated discipline).

• Demonstrated experience conducting and leading GCP audits; experience with inspections preferred

• Experience leading and advancing a global team of direct reports

• Excellent communication, organization, investigation, and negotiation skills, and be diplomatic

• Strong knowledge of drug development, global regulations (e.g., FDA, ICH), and clinical trial risk management

• Ability to prioritize effectively and work in a fast‑paced, global environment

• Willingness to travel up to 20%, domestically and internationally

Required Skills:

Preferred Skills:

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Critical Thinking, Developing Others, Inclusive Leadership, Leadership, Project Management, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Compliance, Risk Management, Tactical Planning, Team Management, Third-Party Auditing