Associate Director, R&D Corrective Actions

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
Job Summary

We are seeking an experienced Associate Director to lead our R&D Corrective Actions (CAPA) Operations Management team. The successful candidate will oversee the R&D CAPA program, ensuring its effectiveness and continuous improvement.

Key Responsibilities
  • Lead the R&D CAPA program, ensuring adherence to regulations and industry best practices.
  • Develop and maintain CAPA procedures, policies, and documentation specific to R&D activities.
  • Establish a continuous improvement program for CAPA operations, driven through performance measures and lessons learned opportunities.
  • Implement, monitor, and report CAPA performance measures at senior leadership meetings and quality forums.
  • Team lead for CAPA Operations, including management of employees and contractors.
  • Collaborate with cross-functional teams to develop and implement effective and timely CAPAs.
  • Approve all R&D originating CAPA plans and approve all CAPA closures.
  • Monitor the effectiveness of implemented CAPAs through regular follow-ups.
  • Support business and investigation teams on quality issues/events investigations.
  • Interface with internal and external stakeholders, including presenting at appropriate engagements.
  • Responsible for the continued maturity of the CAPA program, including quarterly report-out to senior leadership.
  • Prepare for and support regulatory inspections and audits related to R&D CAPA activities/operations.
  • Stay informed of regulatory changes and industry trends affecting R&D quality management.
Requirements
  • Bachelor's degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering). Advanced degree preferred.
  • Minimum of 8-10 years of experience in the biotechnology or pharmaceutical industry, with a focus on CAPA management and Quality Systems.
  • Strong knowledge of GxP regulatory requirements (FDA, EMA, ICH) and industry standards.
  • Proven track record in lean six sigma, total quality system, or similar methodologies.
  • Experience in leading investigations, root cause analysis, and CAPA implementation within an R&D/Manufacturing environment.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong leadership and project management abilities.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a fast-paced, dynamic environment.
About Gilead Sciences International, Ltd.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.

Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer, and inflammation, and serious respiratory and cardiovascular conditions.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission.

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