Director – GCP Quality Assurance Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary quality lead for clinical development at Prilenia, managing GCP quality from the beginning of studies to inspection readiness, while serving as the QA counterpart for our CRO(s) and Ferrer's QA team.

• Function as the sponsor QA representative to CRO QA teams and Ferrer's QA function, ensuring quality oversight of outsourced trial execution, aligning on standards, and addressing issue escalation.

• Supervise eTMF quality, handle protocol deviations and GxP non-conformances, drive the resolution of CAPA with CROs and sites, and maintain ongoing inspection readiness.

• Lead the preparation and management for inspections by regulatory authorities (FDA, EMA, MHRA, PMDA); act as the main QA contact, coordinate responses to observations, and ensure closure of regulatory commitments.

• Write and update GCP and related SOPs; establish and monitor quality metrics and KPIs for senior leadership.

• Manage audits of clinical sites, CROs, and vendors; review audit reports, oversee CAPA resolution, and review and approve Quality Agreements.

• Collaborate as a GVP QA partner and subject matter expert with Drug Safety; oversee pharmacovigilance systems, vendor quality performance, and audits; aid in resolving CAPA for safety findings; ensure adherence to EU GvP modules, FDA 21 CFR Part 312, and ICH E2 series.

• Act as a GLP QA partner and subject matter expert for externally conducted pre-clinical studies; ensure compliance with OECD Principles of GLP and relevant national regulations.

• Contribute to the development of Prilenia's fit-for-purpose Quality Management System (QMS), manage the SOP lifecycle, track quality events, facilitate training, and provide regulatory intelligence.

• Represent QA on clinical program teams and relevant governance forums.

• Promote a proactive quality and compliance culture, positioning quality as a facilitator of clinical program success rather than merely a compliance task.

• Mentor junior QA personnel and encourage professional growth within the quality function.

⛳️ Requirements

• A Bachelor’s degree or higher in life sciences, pharmacy, or a related field; an advanced degree (MSc, PharmD) is preferred.

• At least 10 years of GCP QA experience in the pharmaceutical, biotechnology, or CRO sectors, with a minimum of 3 years in a leadership or director-level role within a biotech company.

• Proven expertise in GCP, GvP, and GLP quality frameworks; practical experience in conducting and overseeing audits across all three areas.

• In-depth understanding of ICH E6(R2/R3), ICH E2 series, FDA 21 CFR Parts 11/50/54/56/312, EU Clinical Trials Regulation (No. 536/2014), EU GvP modules, and OECD Principles of GLP.

• Demonstrated experience in leading or managing successful regulatory authority inspections (FDA, EMA, MHRA, or equivalent).

• Experience in establishing or significantly developing a QMS in a small to mid-sized pharmaceutical environment.

• Competence with eTMF systems (e.g., Veeva Vault, Wingspan) and electronic QMS platforms.

• Excellent communication skills; capable of translating complex regulatory requirements into clear guidance for various audiences.

• Highly independent, proactive, and resilient; thrives in a fast-paced, resource-efficient setting.

• Background in neurology, neurodegenerative disease, or rare disease clinical programs is desirable.

• Knowledge of risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate strategies is advantageous.

🏝️ Benefits

• Flexible schedule

• Frequent calls across Israel, North America, and Europe time zones

• Occasional travel, including internationally within the US and Europe, is required