Assoc. Director QA Clinical Team Lead

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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 companys 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 riskbased 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 expertlevel knowledge of GCP/GxP regulations and global regulatory expectations

• Lead and contribute to crossfunctional 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 fastpaced global environment

• Willingness to travel up to 20% domestically and internationally

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