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Vice President, Quality and Regulatory
Company Overview
Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs.
Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes.
Protara was named one of the Best Places to Work by BioSpace, a leading industry news and job source. This honor demonstrates the company's desirability in the recruitment marketplace, looking at various merits with an emphasis on culture, career growth and development opportunities, leadership and innovation. Attracting and retaining top talent is integral to building a successful company in biotech, and we are committed to ensuring Protara provides our employees with an exceptional experience throughout their careers, even as we continue to grow.
This role is based on site in Winston Salem, North Carolina.
The Vice President, Quality and Regulatory will report to the Chief R&D Officer and will assume leadership of the following duties:
Job Overview:
- Oversight and management of all quality systems.
- Sign-off of batch and material release documentation.
Essential Duties and Responsibilities:
- Lead and evolve the CDMO's Quality Compliance strategy for applicable GMP manufacturing operations, ensuring readiness for both clinical and commercial production.
- Ensure full alignment with GMP, GLP, and GCP standards, which govern manufacturing, preclinical testing, and clinical-trial-related material production, respectively.
- Ensure regulatory compliance across manufacturing, documentation, data integrity, and quality systems per globally recognized regulatory standards.
- Oversee QA, QC, and Quality Systems, including deviations, CAPAs, change controls, risk management, stability oversight, and analytical method validation support.
- Build a robust Quality Management System (QMS) aligned with CDMO best practices: SOP governance, GMP adherence, and ongoing process monitoring.
- Partner closely with Technical Operations, Regulatory Affairs, and Analytical Development to ensure that process development, and manufacturing adhere to quality standards.
- Support phase-appropriate Quality/Regulatory needs including documentation, regulatory submissions, and quality governance.
Qualifications:
- Proven expertise in audit management, inspection readiness, CAPA governance, deviation management, and quality risk management systems.
- Strong command of global regulatory frameworks, including expectations in data integrity, documentation, and GxP compliance.
Education and/or Experience:
- Advanced degree (Master's or PhD) in Pharmaceutics, Biochemistry, Biochemical Engineering, Microbiology, or related life science fields preferred.
- 20+ years of progressive Quality leadership experience in GMP-regulated biologics/pharmaceutical manufacturing, including microbial or bacterial system experience.
- Significant experience in clinical and commercial readiness, including scale-up, process validation, regulatory inspections, and marketing -authorization support.
Physical Demands
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Average travel for this position is 20% with some variations based on the demands of the business needs.
- Must be willing to travel to New York City office as needed.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- No specific work demands.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Why You'll Love Working at Protara
- Friendly, open, and fun team-oriented culture that values unique & diverse perspec
