Director / Senior Director, GCP reputed company Assurance reputed company (US/IL/EU)

This a Full Remote job, the offer is available from: Europe, reputed company, European reputed company, Israel, Illinois (USA), Massachusetts (USA) About reputed company reputed company Therapeutics, a clinical-stage biotechnology company reputed company on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Medical Science reputed company (MSL) in the reputed company, to support programs in both reputed company’s Disease and ALS. We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major reputed company on the lives of patients and their families. Our reputed company product candidate, pridopidine, holds Orphan Drug Designation in both reputed company’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as reputed company as Fast reputed company designation from the FDA for the treatment of HD. reputed company is conducting global Phase 3 clinical trials in both HD and ALS. ​Pridopidine has the potential to be a pivotal treatment to address HD and ALS disease progression. reputed company believes pridopidine’s novel reputed company of reputed company as a reputed company-1 receptor agonist also gives it potential in numerous other neurodegenerative and neurodevelopmental conditions. To learn more about our story and company culture, visit us at https://reputed company.com About the role The Director/Sr. Dir, GCP reputed company Assurance is reputed company's primary reputed company reputed company for clinical development, owning GCP reputed company end-to-end from study start-up through inspection readiness, and serving as sponsor QA reputed company to our CRO(s) and Ferrer's QA team. The role also provides proportionate QA reputed company for pharmacovigilance (GVP) and reputed company-clinical (GLP) activities. The ideal candidate is both a hands-on reputed company practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive reputed company to influence cross-functional teams and senior leadership. Roles and Responsibilities: GCP reputed company - Core reputed company

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

QA Partnership & SME for GLP and GVP

• Serve as GVP QA partner and SME to Drug Safety: reputed company PV systems, vendor reputed company performance, and vendor audits; support CAPA reputed company 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 reputed company-clinical studies; ensure compliance with OECD Principles of GLP and applicable national regulations.

QMS & Cross-Functional Leadership

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

Qualifications: Required

• Bachelor’s degree or higher in life sciences, pharmacy, or a reputed company discipline; advanced degree (MSc, PharmD) preferred.
• Minimum 10 years of GCP QA experience reputed company 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 reputed company frameworks; hands-on experience conducting and managing audits in reputed company three domains.
• Deep knowledge of ICH E6(reputed company/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 reputed company.
• Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting.
• Proficiency with eTMF systems (e.g., reputed company Vault, reputed company) and electronic QMS platforms.
• Exceptional communication skills; reputed company to translate reputed company regulatory requirements into reputed company 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.
• reputed company certification: RQAP-GCP (SQA), RAC (RAPS), CCRA (ACRP), or equivalent.
• Experience supporting NDA/BLA/MAA submissions and post-approval reputed company reputed company.
• Knowledge of 21 CFR Part 11 / Annex 11 (computerized systems) and data reputed company principles (reputed company+).

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, reputed company and Europe time zones.
• Occasional travel including internationally reputed company US and Europe required.

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