Senior Manager, GCP QA
Greater San Francisco
Looking to elevate your career to the next level with an industry leading patient-focused biopharmaceutical company? A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines in Neuroscience, Oncology, and GI is currently seeking a Senior Manager, GCP QA as their company is rapidly expanding! This company has received recognition for their overall success and is looking to increase headcount within the Quality Department. Now is a pivotal time to get in with this group as you will have the ability to lead and impact their robust pipeline of promising new medicines.
The Senior Manager, GCP QA will have the following responsibilities:
- Provide GCP QA leadership to drug development teams.
- Act as a quality expert to provide GCP compliance interpretation, consultation, training, and recommendations.
- Implementation of Audit and Compliance Programs
- Develop and implement a strategic quality plan for assigned compounds.
- Supervise and manage investigations into scientific misconducts and/or serious breach of GCP.
- Assist Takeda R&D during GCP regulatory inspections.
- Rapidly identify, evaluate, and escalate inadequate responses to CCS QA management
- Monitor compliance issues identified across clinical programs. Analyze audit program results, quality issues, and quality investigations in order to optimize global operations and overall global state of compliance.
- Elevate systemic problems with appropriate recommendations/solutions to upper management for immediate and long-term resolution.
- Report metrics for assigned compounds to QA management, clinical staff. Evaluate if CAPA(s) are required and monitor implementation.
- Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures.
The ideal candidate will have:
- S. in Science, Nursing, or related scientific field.
- 5 years GCP QA experience
- Experience in Biotech or Pharma