Director / Senior Director – GCP Quality Assurance Lead

Roles and Responsibilities:

GCP Quality - Core Focus

• Ensure all Prilenia-sponsored trials are conducted, documented, and reported in compliance with applicable regulations, ICH guidelines, and Prilenia's SOPs.
• Serve as Prilenia's day-to-day QA lead for Phase 3 clinical operations, embedded in the program team from protocol review through clinical study report sign-off.
• Act as sponsor QA counterpart to CRO QA teams and to Ferrer's QA function, maintain quality oversight of outsourced trial execution, align on standards, and manage issue escalation.
• Oversee eTMF quality, manage protocol deviations and GxP non-conformances, drive CAPA resolution with CROs and sites, and maintain continuous inspection readiness.
• Lead inspection readiness and management for regulatory authority inspections (FDA, EMA, MHRA, PMDA); serve as primary QA contact, coordinate responses to observations, and oversee regulatory commitment closure.
• Author and maintain GCP and related SOPs; define and track quality metrics and KPIs for senior leadership.
• Oversee clinical site, CRO, and vendor audits; review reports, manage CAPA resolution; review and approve Quality Agreements.

QA Partnership & SME for GLP and GVP

• Serve as GVP QA partner and SME to Drug Safety: oversee PV systems, vendor quality performance, and vendor audits; support CAPA resolution for safety findings; ensure compliance with EU GvP modules, FDA 21 CFR Part 312, and ICH E2 series.
• Serve as GLP QA partner and SME for externally conducted pre-clinical studies; ensure compliance with OECD Principles of GLP and applicable national regulations.

QMS & Cross-Functional Leadership

• Contribute to Prilenia's fit-for-purpose QMS, SOP lifecycle, quality event tracking, training, and regulatory intelligence.
• Represent QA on clinical program teams and relevant governance forums.
• Champion a proactive quality and compliance culture, making quality an enabler of clinical program success rather than a compliance exercise.
• Mentor junior QA staff and foster professional development within the quality function.

Qualifications:

Required

• Bachelor’s degree or higher in life sciences, pharmacy, or a related discipline; advanced degree (MSc, PharmD) preferred.
• 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.
• Demonstrated expertise across GCP, GvP, and GLP quality frameworks; hands-on experience conducting and managing audits in all three domains.
• Deep knowledge 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.
• Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes.
• Experience building or significantly 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; able to translate complex regulatory requirements into clear guidance for diverse audiences.
• Highly autonomous, proactive, and resilient; comfortable in a fast-paced, resource-efficient environment.

Desirable

• Experience in neurology, neurodegenerative disease, or rare disease clinical programs.
• Familiarity with risk-based monitoring (RBM), centralized monitoring, and ICH E6(R3) risk-proportionate approaches.
• Professional certification: RQAP-GCP (SQA), RAC (RAPS), CCRA (ACRP), or equivalent.
• Experience supporting NDA/BLA/MAA submissions and post-approval quality oversight.
• Knowledge of 21 CFR Part 11 / Annex 11 (computerized systems) and data integrity principles (ALCOA+).

Location/Time Zones:

• This is a full-time remote position in the East Coast US, Israel or Europe.
• Flexible schedule with frequent calls across Israel, North America and Europe time zones.
• Occasional travel including internationally within US and Europe required.