Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)
Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS.
We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia 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. Prilenia believes pridopidine’s novel mechanism of action as a Sigma-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://Prilenia.com
The Director/Sr. Dir, GCP Quality Assurance is Prilenia’s primary quality lead for clinical development, owning GCP quality end-to-end from study start-up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s) and Ferrer’s QA team. The role also provides proportionate QA oversight for pharmacovigilance (GVP) and pre-clinical (GLP) activities.
The ideal candidate is both a hands-on quality practitioner and a strategic partner to Clinical Development, Regulatory Affairs, Drug Safety, and Biostatistics, combining deep GCP/GvP/GLP expertise with the executive presence to influence cross-functional teams and senior leadership.
Roles and Responsibilities:
GCP Quality – Core Focus
- Serve as the single point of accountability for GCP quality across all Prilenia-sponsored clinical trials (Phase 2/3, HD and ALS).
- Develop and maintain the clinical quality plan; define risk-based audit and monitoring oversight strategies.
- Author, review, and approve GCP SOPs, quality standards, and trial-specific quality plans.
- Lead and conduct GCP audits of CROs, clinical sites, vendors, and TMF; track and ensure resolution of all findings.
- Oversee and manage the CRO QA relationship, reviewing CRO audit reports and ensuring corrective actions are implemented.
- Lead inspection readiness activities; serve as the primary QA contact during FDA, EMA, MHRA, or other regulatory authority inspections of clinical operations.
- Provide real-time GCP guidance to Clinical Operations, Data Management, Biostatistics, and Medical Affairs.
- Manage the CAPA system for clinical quality issues; ensure timely closure and effectiveness checks.
- Review and approve clinical documents including protocols, ICFs, CSRs, and study plans from a quality perspective.
GVP / Drug Safety Quality
- Provide QA oversight of pharmacovigilance activities in partnership with the Drug Safety team and Ferrer’s PV group.
- Audit PV processes and vendor(s) to ensure compliance with applicable GVP guidelines.
- Support inspection readiness for PV inspections.
GLP / Nonclinical Quality
- Provide proportionate QA oversight of GLP-compliant nonclinical studies conducted at contract laboratories.
- Conduct or oversee GLP facility and study audits; review final study reports for GLP compliance.
QMS & Systems
- Own and continuously improve Prilenia’s Quality Management System (QMS), including the document management system, CAPA system, training system, and deviation/event management.
- Drive the transition to and/or optimization of electronic QMS (eQMS) platforms.
- Establish and report on quality metrics and KPIs to senior leadership and the Board as needed.
Cross-Functional Partnership & Leadership
- Act as a strategic quality advisor to the Chief Development Officer and cross-functional leadership team.
- Collaborate with Regulatory Affairs to ensure quality alignment with IND/CTA/NDA/MAA submissions.
- Work closely with Ferrer’s QA team to align on shared quality standards and inspection strategies.
- Mentor and develop quality staff as the team grows; build a quality-first culture across the organization.
Qualifications:
- Bachelor’s degree in a life science, pharmacy, or related discipline; advanced degree preferred.
- 10+ years of GCP QA experience within the pharmaceutical, biotechnology, or CRO industry.
- 3+ years in a leadership or director-level role, ideally at a small-to-mid-size biotech or in a role with significant independence.
- Demonstrated expertise across GCP, GvP, and GLP quality frameworks; hands-on experience conducting and managing audits in all three domains.
- Proven experience leading or managing regulatory authority inspections (FDA, EMA, MHRA, or equivalent) to successful outcomes.
- Deep knowledge of ICH E6(R3), 21 CFR Parts 11/50/54/56/312, EU CT Regulation, and applicable GVP/GLP regulations.
- Experience building or significantly maturing a QMS in a small-to-mid-size pharmaceutical setting.
- Ability to operate independently in a lean, fast-paced environment; comfortable being both a strategic contributor and a hands-on executor.
- Excellent written and verbal communication skills; able to distill complex quality issues for executive audiences.
- Experience with neurology/rare disease clinical trials is a plus.
- Familiarity with eTMF systems (e.g., Veeva Vault) and eQMS platforms is highly desirable.