Director / Senior Director, GCP Quality Assurance Lead
New
P
Prilenia TherapeuticsBiotechnology
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.
- Required Skills
- GCPQuality Assurance
Requirements
- Bachelor’s degree in life sciences, pharmacy, or related discipline (MSc, PharmD preferred).
- Minimum 10 years of GCP QA experience in pharma, biotech, or CRO.
- At least 3 years of experience in a leadership or director-level role at a biotech company.
- Demonstrated expertise across GCP, GVP, and GLP quality frameworks.
- Hands-on experience conducting and managing audits in GCP, GVP, and GLP.
- Deep knowledge of ICH E6(R2/R3), ICH E2, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation, and OECD GLP.
- Proven experience leading or managing successful regulatory authority inspections (FDA, EMA, MHRA, etc.).
- Experience building or maturing a QMS in a small-to-mid-size pharmaceutical setting.
- Proficiency with eTMF systems (e.g., Veeva Vault, Wingspan) and electronic QMS platforms.
- Exceptional communication skills with executive presence.
- Ability to work autonomously in a fast-paced environment.
- Occasional international travel required.
Responsibilities
- Ensure all Prilenia-sponsored trials comply with ICH guidelines, regulations, and SOPs.
- Act as the primary QA lead for Phase 3 clinical operations from protocol review through study report sign-off.
- Manage quality oversight for outsourced trial execution with CROs and partners.
- Oversee eTMF quality, manage protocol deviations, and drive CAPA resolution.
- Lead inspection readiness and management for regulatory authorities including FDA, EMA, MHRA, and PMDA.
- Author and maintain GCP-related SOPs and track quality metrics for senior leadership.
- Oversee clinical site, CRO, and vendor audits and approve Quality Agreements.
- Serve as GVP and GLP subject matter expert to support drug safety and pre-clinical study compliance.
- Contribute to the QMS, SOP lifecycle, and cross-functional governance forums.
- Mentor junior staff and champion a proactive quality culture.
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