Senior Specialist - Quality Assurance GCP

October 15

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Crinetics Pharmaceuticals

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Drug Discovery • Endocrinology • RareDisease • Biotech

201 - 500

Description

• Support Good Clinical Practice (GCP) quality oversight and compliance program • Plan, oversee, conduct, and report assigned GCP routine audits • Provide GCP guidance for R&D activities • Create, revise, and implement quality SOPs or Work Instructions • Assist in development of GCP compliance processes • Review of CAPAs and deviations; perform root cause analysis • Support regulatory inspections and inspection-readiness activities • Develop cross-functional relationships; foster collaboration • Complete assigned training requirements • Support quality-driven activities and initiatives • Review clinical study documents • Identify trends in quality events; report issues • Support continuous process improvement activities • Interpret and apply regulations of moderate complexity • Coordinate and administer GCP training • Identify and escalate significant compliance risks

Requirements

• Bachelor’s degree with 5 years of quality assurance experience, or equivalent • GCP auditing and compliance experience • Knowledge of FDA and ICH GCP, global regulations • Experience with QMS in vendor management, SOPs, internal audits, CAPAs, deviations • Sound analytical and problem-solving abilities • Collaboration, communication, and interpersonal skills • Excellent verbal and written communication skills • Outstanding organizational, prioritization, and detail-oriented skills • Understanding of organization policies, procedures, and guidelines • Regulatory inspection experience highly desired

Benefits

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Health insurance plans (medical, dental, vision) • Basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown