Director, Quality Assurance GMP Operations

About this opportunity :

The Director, Quality Assurance GMP Operations is responsible for quality oversight of the manufacturing process and operations. This includes leading and managing multiple QA teams for batch record review, batch disposition, and on the floor QA support to ensure GMP compliance across all stages of manufacturing. The role is expected to build strong collaborative relationships with internal and external stakeholders to drive compliance and continuous improvement of GMP operations. 

Key Responsibilities

• Provide quality expertise, oversight of manufacturing processes across shift operations to ensure adherence to GMP standards.
• Establish and monitor quality metrics. Proactively identify trends, gaps, and risks, collaborate with internal and external stakeholders to resolve quality issues and drive operational excellence.
• Manage and provide guidance to the QA team supporting GMP manufacturing activities, batch record review, and batch release.
• Review and approve GMP documents, including deviation, change control, CAPA reports, batch records, SOPs, and material specifications, and analytical documents (test methods, analytical data, stability data and associated protocols and reports).
• Support or lead client audits and regulatory inspections, ensuring inspection readiness.
• Ensure timely and effective communication with clients on Quality topics, addressing any concerns and providing updates on ongoing quality issues or regulatory matters.
• Establishes the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.
• Provide leadership, mentoring, and team development to ensure alignment with company goals and foster a culture of quality.
• Responsible for product and process related Change Management to ensure proper evaluation and risk assessment of changes and to ensure compliance to Regulatory filings.
• Support tech transfer, process validation, and risk-based management activities.
• Support the development / amendment of Quality Assurance Agreements with clients, GMP vendors and key raw material suppliers.
• Evaluate complex quality or multi-disciplinary situations and make decisions utilizing risk-based approach.
• Other ad hoc responsibilities assigned by senior management to support continuous improvement.

Required Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related discipline (Master’s preferred).
• 15+ years of experience in a regulated pharmaceutical environment, with at least 7 years in GMP QA management/supervisory role. 
• Prior manufacturing experience, or experience of close interaction with manufacturing desired. 
• Experience with oligonucleotide API manufacturing, and/or experience working for a CDMO is preferred.
• Current and in-depth knowledge of global cGMP regulatory requirements. regulatory changes, industry trends and best practices. 
• Extensive exposure to multiple regulatory agencies during GMP inspections.
• Proven leadership skills in managing quality to support GMP manufacturing, with experience leading high-performing teams in a fast-paced, deadline-driven environment, and managing complex projects within defined timelines.
• Substantial skills in mentoring staff and transferring technical and regulatory knowledge to enable their capabilities and development.
• Extensive experience in risk management, event investigations, Root Cause Analysis (RCA), and CAPA.
• Experience with electronic QMS systems (e.g., Veeva, Trackwise).