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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCPGLPauditingcompliance activitiesCAPAsSOPsQuality AgreementsQuality by Design (QbD)Critical to Quality (CtQ)inspection readiness

Soft Skills

leadershipcommunicationcollaborationproblem-solvingrelationship buildingcoachingmentoringperformance managementdiplomacyanalysis

Certifications

Auditor certificationRQAP-GCP certification