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Job Description
Azurity Pharmaceuticals is seeking a Director of R&D Quality Assurance to lead and manage QA oversight across multiple critical R&D functions. This role is crucial for ensuring that quality systems and activities align with regulatory expectations and internal standards, supporting product development and successful regulatory submissions.
The role involves:
- Providing strategic and operational QA oversight for R&D Quality Control laboratories.
- Leading QA review and approval of method validation/transfer protocols.
- Overseeing qualification and lifecycle management of R&D laboratory equipment.
- Managing and overseeing the stability program for registration purposes.
- Reviewing CMC submission for approval of new marketing authorization.
- Leading or providing QA guidance on investigations of OOS and OOT results.
- Driving continuous improvement initiatives in QA systems.
- Maintaining inspection readiness and contributing to successful regulatory agency inspections.
- Building, coaching, and managing a high-performing QA team.
- Staying current with global regulatory expectations and industry best practices.
Requirements:
- Bachelor’s or master’s degree in a scientific discipline.
- Minimum 10 years of experience in pharmaceutical/biotech Quality Assurance, with at least 5 years in a leadership role.
- Deep understanding of cGMP, ICH guidelines, method validation/transfer, and regulatory submission requirements.
- Experience in supporting method transfer and validation at CMOs and in overseeing registration stability programs.
Azurity Pharmaceuticals offers:
- An inclusive workplace and is an Equal Opportunity Employer.
