Director, Quality Operations

The Director of Quality Operations will lead and oversee all Quality Assurance, Quality Control, Documentation and Microbiology operations for three GMP manufacturing sites. This individual will ensure compliance with cGMP regulations, GLP, and global regulatory requirements while ensuring that manufacturing processes meet the highest quality standards. The Director will implement and maintain robust quality systems, lead continuous improvement initiatives, and ensure that all products and processes adhere to regulatory standards and industry best practices.

Essential Duties & Responsibilities:

• Formulate, implement, and maintain quality policies, procedures, and systems to ensure compliance with cGMP, GLP, and other global regulatory standards in a GMP manufacturing environment.
• Establish and maintain an overall Quality Management System (QMS) across the manufacturing sites to ensure that all activities are compliant with internal and external regulatory requirements.
• Oversee and direct all QA, QC, and Microbiology activities, including product testing, release, and disposition, ensuring products meet all regulatory and quality standards.
• Supervise and manage the Quality Control laboratory and microbiological testing functions to ensure the highest standards of product testing and batch release.
• Lead and manage preparations for regulatory inspections (FDA, EMA, etc.), ensuring all documentation and processes are inspection-ready.
• Oversee the execution of internal and external audits, including GMP audits, vendor audits, and inspections by regulatory agencies, ensuring timely and thorough responses to audit findings.
• Collaborate with technical operations teams to drive continuous improvement initiatives aimed at enhancing product quality, operational efficiency, and compliance.
• Identify, investigate, and resolve any quality-related issues or deviations, ensuring corrective and preventive actions (CAPA) are implemented and tracked.
• Lead and develop a high-performing quality team across both sites, including hiring, training, and retaining staff (including contractors). Provide mentorship and development opportunities to Quality team members to foster career growth and maintain an effective and capable team.
• Oversee the development and management of quality-related training programs, ensuring that all personnel receive adequate training to perform their roles in compliance with cGMP and safety regulations.
• Manage document control systems, ensuring that all documents are accurate, up to date, and compliant with regulatory requirements.
• Establish and maintain systems for vendor qualification, including auditing and ensuring that vendors comply with GXP requirements.
• Work closely with procurement and supply chain teams to ensure suppliers meet required quality standards and regulatory guidelines.
• Lead risk assessments, ensuring the identification, evaluation, and mitigation of risks to product quality and regulatory compliance.
• Provide regular updates and reports to senior management regarding quality system performance, regulatory inspections, deviations, CAPA, and overall manufacturing quality status.
• Develop and implement long-term strategies for improving quality systems, ensuring alignment with company goals and regulatory expectations.
• Ensure that the quality strategy supports manufacturing scale-up, process changes, and new product introductions, with a focus on maintaining compliance and operational excellence.

Experience/Qualifications:

• Bachelor’s degree in a scientific discipline is essential. A Master’s degree or higher is a plus.
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 5-10 years in a quality assurance or manufacturing quality leadership role.
• Experience in Large Molecules and Biologics is essential.
• Extensive experience in GMP manufacturing environments, with deep knowledge of pharmaceutical regulations and regulatory inspections.
• Proven success in leading pre-approval inspections and managing interactions with regulatory agencies.
• Strong background in managing QA, QC, and Microbiology teams and operations across multiple sites.