Manager, External Quality at The Fountain Group

The Fountain Group. We are a national staffing firm and are currently seeking a Manager, External Quality for a prominent Pharmaceutical client of ours. This position is in South San Francisco, CA (Hybrid Role). Details for the position are as follows:
 
Job Description:

• Pay: 54.00-68.92/hr on W2.
• 12-month assignment to start with potential for extension or conversion.
• Hybrid role: 50 percent onsite/50 percent remote.
• BS/BA degree required and 5+ years in PV or compliance-related role.
• Based on identified risks and process gaps, the GMP Technical Manager, External Quality is responsible for developing and executing the strategic oversight plan for ensuring GMP vendor compliance in accordance with Affiliate Complaint Management and Pharmacovigilance (PV) Vendor compliance per health authority and global Roche requirements.
• Makes all decisions around the day-to-day operations of the oversight plan, and continuously monitors stakeholder feedback to inform PV Vendor quality improvements and updates.
• Demonstrates expertise in the vendor management framework set by the Head of O&I translates the requirements into reporting deliverables (e.g., KPI, metrics, action items, etc.).
• Accountable for the Service Provider Oversight Plans for PV vendors in alignment with SOP requirements to monitor overall performance.
• Leads the vendor management plan including structure, governance, communication, and metrics.
• Performs consistent re-evaluations of the vendor management plan and strategic priorities to align to the changing GMP and PV landscape.
• Act as GMP Pharmacovigilance subject matter expert for PV Vendor processes in the event of audit or regulatory inspections.
• Advanced analytic and computer skills (e.g., Microsoft Excel, other data visualization tools).