Associate Director, Quality Assurance GCP

Crinetics is a pharmaceutical company based in San Diego, California that develops therapies for rare endocrine diseases. This role will help transform the lives of patients by ensuring high‑quality clinical trial conduct and regulatory readiness.Position SummaryThe Associate Director, Quality Assurance GCP supports the Good Clinical Practice (GCP) QA function, performs day‑to‑day GCP QA operations, and leads risk‑based quality oversight across clinical phases 1–4.ResponsibilitiesManage or perform clinical site, internal, TMF, GCP, and GLP vendor audits.Generate and review GCP and GLP QA audit plans, schedules, and trend reports.Communicate, address, and prevent identified GCP compliance issues and trends.Develop and manage audit programs and represent QA at program‑wide meetings.Serve as point of escalation for GCP compliance issues identified by study teams or QA leads.Embed Quality‑by‑Design (QbD) and Critical‑to‑Quality (CtQ) principles into study planning.Investigate, manage, and track GCP CAPAs, deviations, and other quality issues.Collaborate with cross‑functional teams to strengthen data integrity, governance, and participant protection.Assist with serious breach assessments and notifications per regional requirements.Provide guidance and support to Trial Master File activities and review study‑specific documents.Attend governance meetings, identify and address quality system gaps, and improve processes.Author, review, or revise SOPs, Work Instructions, Policies, and Job Aids.Deliver training to internal and external stakeholders.Support regulatory inspections, mock interviews, and inspection readiness activities.Prepare clinical sites for inspection readiness.Develop compliance strategies and provide input on vendor selection and oversight.Prepare and/or assess key quality metrics for continuous improvement.Draft and recommend Quality Agreements for GCP/GLP vendors.Direct and supervise personnel, including coaching, mentoring, and performance management.Perform other duties as assigned.QualificationsRequired:Bachelor’s degree in a science discipline or equivalent combination of education and experience.Minimum 10 years of QA experience in the pharmaceutical/biotech industry.At least 7 years of supervisory or leadership experience.Minimum 5 years of working in a QA GCP function.Previous experience in inspection readiness and audits.Previous experience in developing and implementing compliance activities.Strong knowledge of FDA, EU, and ICH GCP guidelines.Ability to interpret and apply regulatory guidance to study design and execution.Excellent interpersonal, collaboration, organization, and multi‑tasking skills.Strong analytical skills for complex investigations and issue resolution.Preferred:Knowledge of GVP and GLP.Auditor certification and/or RQAP‑GCP certification.Physical Demands & Work EnvironmentWork is performed at a desk for extended periods with intermittent phone calls and keyboard use. Some walking and lifting up to 25 lbs. may be required. Typical office noise is low to moderate. Reasonable accommodations can be made for disabilities.TravelUp to 40% travel may be required.CompensationSalary range: $150,000 – $186,000. Total rewards include discretionary annual bonus, stock options, ESPP, 401(k) match, and comprehensive benefits (health, dental, vision, life insurance, 20 days PTO, 10 holidays, and a winter company shutdown).Equal Opportunity EmployerCrinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to sex, sexual orientation, gender identity, pregnancy, race, color, creed, national origin, citizenship status, religion, disability, marital status, age, genetic information, veteran status, or any other protected characteristic under applicable law. #J-18808-Ljbffr