Director, R&D Quality Assurance

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

The Director of R&D Quality Assurance (QA) will be responsible for leading and managing QA oversight across multiple critical R&D functions. This includes Quality Control for R&D, equipment qualification, internal method transfer to CMOs and between CMOs for validation and registration, stability program oversight, and investigations of Out-of-Specification and Out-of-Trend results. The role ensures that quality systems and activities align with regulatory expectations (FDA, EMA, ICH, etc.) and internal standards, supporting product development and successful regulatory submissions.

Principle Responsibilities:

• Provide strategic and operational QA oversight for R&D Quality Control laboratories, ensuring compliance with cGMP and GLP regulations.
• Lead QA review and approval of method validation/transfer protocols and reports for methods transitioning from internal R&D to CMOs for registration and validation purposes, and between CMOs as part of horizontal Tech Transfer activities.
• Oversee qualification and lifecycle management of R&D laboratory equipment, including review and approval of URS, IQ/OQ/PQ, and calibration/maintenance documentation.
• Collaborate cross-functionally with Analytical Development, Formulation, Regulatory Affairs, and Technical Operation to ensure robust quality oversight of CMO activities.
• Manage and oversee the stability program for registration purposes, including protocol development, data review, trending, and reporting.
• Review CMC submission for approval of new marketing authorization and for post-approval changes of approved products.
• Lead or provide QA guidance on investigations of OOS and OOT results, ensuring timely, thorough, and compliant root cause analysis and CAPA implementation.
• Drive continuous improvement initiatives in QA systems, processes, and documentation related to R&D quality support.
• Maintain inspection readiness and contribute to successful regulatory agency inspections and partner audits.
• Build, coach, and manage a high-performing QA team to support R&D functions.
• Stay current with global regulatory expectations, industry best practices, and emerging trends in R&D QA.

Qualifications and Education Requirements

• Bachelor’s or master’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
• 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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.