Director of R&D Corrective Actions Operations
3 weeks ago
About the Role
The Director of R&D Corrective Actions Operations will oversee the R&D CAPA program, ensuring its effectiveness and continuous improvement. This role involves managing CAPA administration, CAPA training, setting record standards, and maintaining high-quality standards for records and data.
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, building visibility into R&D's CAPA strategy and overall impact on QMS performance.
- Responsible for the continued maturity of the CAPA program, including quarterly report-out to senior leadership through management reviews.
- 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.
- Collaborate with departments across R&D to ensure effective integration and use of CAPA systems and procedures.
- Support the development and training of internal staff, including fostering a commitment to quality in individuals and a culture of quality within the organization.
- Develop and deliver training and learning programs related to CAPA processes and quality systems for R&D staff.
- Mentor and coach R&D team members on effective CAPA management and problem-solving techniques.
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