Associate Director, R&D Corrective Actions Leader
2 weeks ago
About the Role
The Associate Director of R&D Corrective Actions Operations Management is responsible for overseeing the R&D CAPA program and associated processes, ensuring their 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 both 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.
- 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.
About Gilead R&D Quality
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide opportunities to be challenged and stretched while supported and developed by our diverse and expert team.
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