San Francisco Bay Area
BD - 10
27 days ago
Senior Director, GCP Quality Assurance & Pharmacovigilance
Location: San Francisco Bay Area
Type: Full Time Permanent
Salary: Excellent salary, bonus and accompanying benefits package
My client is a Global Rare Disease Biopharmaceutical with a recent NDA submission and a strong clinical pipeline. This position is due to fast growth and reports to the VP of Quality.
Exciting opportunity for a strong GCP QA specialist with a supplemental background in PV to drive the team focuses in establishing and executing global GCP and PV process, standards, and compliance monitoring systems. Multi-faceted role for a strong, clinical biopharmaceutical!
This candidate will be responsible for ensuring GCP and PV Inspection readiness and continuous process improvement. As the GCP lead, the right candidate requires the proven ability to make and be accountable for strategic decisions to meet the ever changing and stringent global GCP requirements. This person will be a key member of the leadership team of the QA organization of my client
- Leads inspection readiness activities including but not limited to monitoring for non-compliance and ensuring responsible functions mitigate risks for GCP and PV audits.
- Reviews and analyzes audit, inspection and CAPA data to identify compliance trends and areas of exposure related to GCP and pharmacovigilance.
- Collaborates with internal and external stakeholders to ensure appropriate GCP and PV systems are implemented and maintained.
- Provides expert compliance advice on GCP and PV strategies, programs, processes, initiatives, and activities to help manage and mitigate risk.
- Constantly review existing SOPs and determines the need for changes and updates according to new procedural documents
- Maintains records of internal and external audit deficiencies and communicate with functional heads in preparing, prioritizing and monitoring a reparation schedule.
- Bachelors Degree required (Masters, PharmD, or PhD preferred)
- At least 8 years in GCP Quality w/ some exposure to PV, which may include working knowledge of safety reporting of clinical trials
- Leadership experience regarding running a team of compliance professionals
- Experience in quality systems, establishing/tracking metrics, compliance monitoring, and development of SOPs
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (646) 359 4344.