Description

Act as the R&D Quality Business Partner for assigned functions and vendors, providing strategic advice on GCP quality, risk, and continuous improvement.

Responsibilities

• Lead quality business partner activities for assigned R&D functions, programs, and vendors.
• Serve as Subject Matter Expert for GCP cross-portfolio risk assessment and mitigation.
• Collaborate with Audit, Inspection, and CAPA teams on internal audits, regulatory inspections, and deviation management.
• Write, evaluate, and review standard operating procedures (SOPs) to support an integrated Quality Management System (QMS).
• Support readiness preparation and direct participation in regulatory agency inspections.

Required Skills

• PharmD or PhD with 2+ years of experience; MA, MS, MBA with 8+ years; or BA/BS with 10+ years.
• Extensive experience advising biopharmaceutical business functions on GCP quality, compliance, and evolving regulations.
• Proven track record in GCP quality at a Sponsor or CRO.
• Experience managing quality activities including authoring SOPs, internal auditing, and supporting regulatory inspections.
• Direct experience developing and managing CAPAs and deviations.
• Hands-on experience with GCP regulations and risk minimization.
• Deep understanding of GCP, SOPs, and quality management systems.
• Ability to lead or support cross-functional projects related to clinical trials or drug development.

Key Skills

Education

PharmD/PhD