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📍 Location: United States (Full-time, Onsite/Hybrid depending on role scope)
Azurity Pharmaceuticals, a leader in specialty pharmaceutical innovation, is hiring a Director of R&D Quality Assurance (QA) to spearhead regulatory excellence across our R&D Quality Control and stability programs. If you’re a quality-driven leader with deep cGMP, ICH, and FDA/EMA expertise, and a passion for improving patients’ lives, we want you on our team.
🔬 About Azurity Pharmaceuticals
We are a privately held pharmaceutical company focused on unique, high-quality treatments for underserved patient populations. With a broad commercial product portfolio and robust late-stage pipeline, we’re making a real impact in cardiovascular, neurology, GI, endocrinology, institutional, and orphan drug markets.
🌐 Learn more: www.azurity.com
🧪 Role Overview: Director – R&D QA
You’ll lead strategic and operational quality oversight across key R&D areas:
- Quality Control (R&D labs)
- Equipment qualification & lifecycle management
- Internal & CMO method transfer/validation
- Regulatory submission & stability data integrity
- Investigations (OOS/OOT) & CAPA
- Cross-functional collaboration with Formulation, Analytical Development, Regulatory, and Tech Ops
This role ensures inspection-readiness, quality systems alignment with global regulatory expectations (FDA, EMA, ICH), and leadership in continuous improvement.
🎯 Key Responsibilities
- Lead QA compliance for R&D QC labs under cGMP/GLP standards
- Approve method validation/transfer docs for CMO and internal transfers
- Oversee registration stability program protocols, trending, and data analysis
- Manage equipment qualification (URS, IQ/OQ/PQ, calibration docs)
- Review CMC sections of regulatory filings and post-approval change controls
- Drive timely OOS/OOT investigations with robust root cause and CAPA
- Prepare for regulatory inspections and partner audits
- Build and mentor a high-performing QA team
- Implement continuous improvement initiatives in QA systems and documentation
✅ Candidate Profile
- Bachelor’s or Master’s in Chemistry, Biology, Pharmacy, or related field
- 10+ years in Pharma/Biotech QA, with 5+ years in leadership roles
- Strong knowledge of cGMP, ICH guidelines, and regulatory submissions
- Proven track record managing method transfers at CMOs and stability programs
- Strong cross-functional communication and leadership capabilities
💼 Why Join Azurity?
- Work on impactful, life-saving products
- Thrive in a collaborative, patient-centric culture
- Competitive compensation and benefits
- Equal Opportunity Employer – we value diversity and inclusion
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