Senior Consultant, Quality and Compliance
On-site · Remote, Oregon, United States or US
Job Summary
Senior Consultant, GCP quality and compliance role leading sponsor-facing quality programs for virtual and emerging biotech clinical programs (Phase 1–3). Independent, client-facing position driving sponsor oversight of CROs and vendors, auditing investigator sites and systems, and ensuring inspection-readiness against FDA/EMA/ICH GCP expectations. Responsibilities include developing and approving quality plans and audits, authoring CAPAs and regulatory documents, leading PAI readiness and mock inspections, maintaining TMF/eTMF quality, and providing regulatory input on submissions. Requires extensive GCP audit experience, strong technical writing, ability to manage multiple engagements, and capability to grow existing accounts; emphasis on independent decision-making, stakeholder influence, and strategic quality leadership.
Required Qualifications
- Bachelor's degree required: life sciences, chemistry, pharmacy, nursing, or related discipline
- 10+ years of experience in GxP environments with at least 8 years of GCP experience in sponsor/CRO/consulting
- Lead clinical quality audits across investigator sites, CROs, central labs, and clinical vendors (minimum 25 audits)
- Direct experience supporting FDA BIMO inspection or EMA/MHRA inspection
- Experience with RBQM and risk-based quality management
- Phase 1-3 experience; preference for virtual/emerging biotech sponsors
- Strong knowledge of ICH guidelines and 21 CFR parts related to clinical trials
- Fluency with eTMF/eCRF/CTMS platforms and related systems
- Ability to manage multiple engagements concurrently
- Experience in remote or decentralized trials (preferred)
- Interim or virtual Head of Clinical Quality experience (preferred)
- Oncology/rare disease experience (preferred)
- Device/combination product clinical trial knowledge (preferred)
Desired Qualifications
- Bachelor's degree in life sciences, chemistry, pharmacy, nursing, or related discipline
- Advanced degree (MS, PharmD, PhD, or MPH) preferred
- Professional certification valued: RQAP-GCP, SQA, ACRP-CP, or equivalent
- Experience auditing or supporting decentralized clinical trials (DCTs), hybrid trials, and remote source data verification programs
- Experience in oncology, rare disease, cell and gene therapy, or other complex clinical programs with elevated quality oversight demands
- Prior experience as an interim or virtual Head of Clinical Quality for a sponsor client
- Familiarity with combination product and device clinical trial requirements (21 CFR Part 812; ISO 14155)
- Former regulatory authority experience (FDA, EMA, MHRA) or recognized industry thought-leadership
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