Associate Director, Quality Assurance, GCP

Role Overview

• support the Good Clinical Practice (GCP) Quality Assurance (QA) function
• perform day-to-day GCP QA operations
• execute and/or ensure proper oversight of GCP QA activities
• perform external and internal audits
• support clinical phase 1 to phase 4 study team activities
• review documents
• support regulatory inspections
• enhance GCP QA infrastructure development
• manage or perform clinical site, internal, TMF, GCP, and GLP vendor audits
• generate and/or review GCP and GLP QA audit plans and schedules
• generate and/or review and approve audit trend reports across programs
• communicate, address, and prevent identified GCP compliance issues and trends
• develop and manage audit programs
• represent QA at program-wide meetings
• serve as point of escalation for GCP compliance issues
• embed Quality ‑ by ‑ Design (QbD) and Critical ‑ to ‑ Quality (CtQ) principles into study planning and execution
• investigate, manage, and track GCP CAPAs, deviations, and other quality issues
• collaborate with cross-functional teams
• assist with serious breach assessments and notifications
• provide guidance and support to Trial Master File activities
• review study-specific documents
• partner with cross-functional groups and promote compliance
• attend governance meetings
• identify and address quality systems gaps
• author, review, or revise SOPs, Work Instructions, Policies, and Job Aids
• deliver training to internal and external stakeholders
• support regulatory inspections and inspection readiness activities
• prepare clinical sites for inspection readiness
• draft and recommend Quality Agreements for GCP/GLP vendors
• direct/supervise personnel; including coaching, mentoring, development, and performance management

Requirements

• Bachelor’s degree in a science discipline
• at least 10 years’ experience in a QA function within the pharmaceutical/biotech industry
• minimum of 7 years’ supervisory/leadership experience
• minimum of 5 years of working in a QA GCP function
• previous experience in inspection readiness and audits
• previous experience in developing and implementing compliance activities
• proven ability to cultivate and develop relationships with cross functional teams, vendors, sites, and other stakeholders
• proven ability to interpret applicable FDA, EU and ICH guidelines related to GCP
• strong working knowledge of GCP regulations
• ability to assess issues, perform thorough analysis on complex investigations, and resolve issues in a diplomatic and expeditious manner
• GVP and GLP knowledge, a plus
• Auditor certification and/or RQAP-GCP certification, a plus

Tech Stack

• Google Cloud Platform

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• top-notch health insurance plans for employees (and their families)
• medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown