Associate Director Quality Assurance

Reports To: Vice President, Regulatory Affairs, Drug Safety, Quality

FLSA Status: Exempt

Job Type: Full-time

The Associate Director, Quality Assurance is responsible for supporting the execution of Accord Bio Pharma's Quality Management System (QMS) while ensuring compliance with FDA, ICH, cGMP, and global quality standards across commercial operations, contract manufacturing organizations (CMOs), suppliers, and distribution partners. This position leads Quality Assurance operations supporting commercial manufacturing, product release, supplier oversight, quality systems, regulatory inspections, and continuous improvement initiatives.

The Associate Director partners closely with Manufacturing, Regulatory Affairs, Supply Chain, Pharmacovigilance, Medical Affairs, Commercial Operations, Technical Operations, Global Quality, and external manufacturing partners to ensure products consistently meet quality, regulatory, and patient safety requirements. This role serves as the operational Quality Assurance leader responsible for executing quality strategies while supporting Accord Bio Pharma's commitment to operational excellence and global quality compliance.

• Lead day-to-day Quality Assurance operations supporting commercial pharmaceutical manufacturing and distribution activities.
• Oversee internal manufacturing operations and Contract Manufacturing Organizations (CMOs) to ensure compliance with FDA regulations, cGMP requirements, ICH guidelines, and company quality standards.
• Ensure effective implementation and maintenance of the Quality Management System (QMS) across commercial operations.
• Monitor quality metrics, trends, and performance indicators while recommending continuous improvement initiatives.
• Support quality risk management activities utilizing science-based and risk-based decision-making methodologies.
• Ensure compliance with applicable regulatory requirements including FDA, EMA, ICH, USP, and other international quality standards.
• Serve as the Quality Assurance representative responsible for commercial batch disposition and finished product release activities.
• Review and approve Certificate of Analysis (CoA) documentation and batch release packages.
• Evaluate manufacturing documentation, laboratory testing results, deviations, investigations, and change controls prior to product disposition.
• Ensure product release decisions comply with internal quality standards and regulatory requirements.
• Support management of product stability programs and Annual Product Quality Reviews (APQRs).
• Lead investigations involving deviations, Out-of-Specification (OOS) results, Out-of-Trend (OOT) investigations, customer complaints, and non-conformance events.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully meet the expectations listed above.

Education and Experience:

• Bachelor’s degree in pharmacy, Pharmaceutics, Chemistry, Biology, Microbiology, Chemical Engineering, Life Sciences, or a related scientific discipline required.
• Master's degree in a scientific discipline or MBA preferred.
• Minimum of 10 years of progressive Quality Assurance, Quality Systems, Manufacturing Quality, or Regulatory Compliance experience within the pharmaceutical, biotechnology, or life sciences industry.
• Minimum of 5 years of experience supporting commercial pharmaceutical manufacturing, generic pharmaceutical development, or specialty pharmaceutical products.
• Demonstrated experience supporting FDA-regulated manufacturing operations, Quality Management Systems (QMS), and cGMP compliance.
• Experience overseeing Contract Manufacturing Organizations (CMOs), contract laboratories, and supplier quality programs.
• Demonstrated experience conducting supplier, internal, and regulatory audits.
• Experience leading investigations involving deviations, OOS, OOT, CAPA, change control, customer complaints, and quality risk assessments.
• Experience supporting FDA inspections and international regulatory audits, including preparation, hosting, and response development.
• Experience reviewing and approving batch records, Certificates of Analysis (CoAs), Annual Product Quality Reviews (APQRs), validation documentation, and quality agreements.
• Experience operating within a global, matrixed pharmaceutical or biotechnology organization preferred.
• Demonstrated experience collaborating with Global Quality organizations to implement enterprise quality systems, governance standards, and compliance initiatives.
• ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification preferred.

Knowledge, Skills, and Abilities:

• Comprehensive knowledge of FDA regulations, cGMP requirements, 21 CFR Parts 210 and 211, ICH guidelines, USP standards, and pharmaceutical quality systems.
• Strong understanding of Quality Management Systems (QMS), quality risk…