Director / Senior Director, GCP Quality Assurance Lead
New
East Coast US, Israel or Europe, Flexible schedule with frequent calls across Israel, North America and Europe time zones.Full-TimeDirector
Salary not disclosed
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Job Details
- Experience
- Minimum 10 years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership or director-level role at a biotech company.
- Required Skills
- GCPQA
Requirements
- Bachelor’s degree or higher in life sciences, pharmacy, or related discipline.
- Minimum 10 years of GCP QA experience in pharma, biotech, or CRO.
- Minimum 3 years in a leadership or director-level role at a biotech.
- Demonstrated expertise across GCP, GvP, and GLP quality frameworks.
- Deep knowledge of ICH E6(R2/R3), ICH E2 series, and FDA 21 CFR Parts 11/50/54/56/312.
- Knowledge of EU Clinical Trials Regulation and OECD Principles of GLP.
- Proven experience leading or managing regulatory authority inspections.
- Experience building or maturing a QMS in a small-to-mid-size pharma setting.
- Proficiency with eTMF systems (e.g., Veeva Vault) and electronic QMS.
- Highly autonomous, proactive, and resilient.
Responsibilities
- Ensure trial compliance with regulations, ICH guidelines, and SOPs.
- Serve as day-to-day QA lead for Phase 3 clinical operations.
- Act as sponsor QA counterpart to CRO QA teams and partners.
- Oversee eTMF quality, manage protocol deviations, and drive CAPA resolution.
- Lead inspection readiness and management for regulatory authority inspections.
- Author and maintain GCP and related SOPs.
- Oversee clinical site, CRO, and vendor audits.
- Serve as GVP and GLP QA partner/SME.
- Contribute to QMS, SOP lifecycle, and quality event tracking.
- Mentor junior QA staff.
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