Associate Director of Quality Operations

Position Overview

The Associate Director of Quality Operations is responsible for providing strategic and operational QA leadership across assigned programs related to clinical and commercial manufacturing operations, with a focus on antibody-drug conjugates (ADCs). This role ensures compliance with global regulatory standards, leads internal and external audits, and drives continuous improvement initiatives. The Director collaborates cross-functionally and with external partners to ensure product quality throughout the development lifecycle and provides strategic quality leadership aligned with company objectives. Experience with biologics and ADCs is required; familiarity with small molecule operations is a plus.

Responsibilities

Quality Operations:

• Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities
• Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
• Disposition early phase through commercial batches.
• Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.
• Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
• Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
• Support vendor qualification program and monitor vendor performance.
• Prompt communication to management of potential compliance issues.
• Participate in internal and external project team meetings.

 Documentation and Record Control:

• Perform periodic reviews and revisions of SOPs, policies, and Quality Agreements to align with regulatory updates and business needs.
• Establish, review and/or approve Quality Agreements and ensure they are properly stored and managed.
• Manage other internal and external documentation related to QA operations

 Regulatory Compliance and Inspection Readiness:

• Ensure external parties are inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
• Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance with filing requirements.
• Support site preparation for regulatory inspections including personnel preparation and training
• Participate in Quality Management Review meetings, as needed.
• Assist in updating CMC sections of regulatory and quality documents

 Operational Leadership and Continuous Improvement:

• Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
• Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
• Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
• Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration.

Qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
• A minimum of 9 years of experience in pharmaceutical, biotechnology, or life sciences industries industry quality assurance. Quality operations and ADC experience is a requirement. 
• Proven experience in managing GMP operations, QMS, including vendor management and CMO oversight.
• Strong knowledge of FDA, EMA, ICH, and other global regulatory guidelines and their application to Quality Operations.
• Experience supporting clinical and commercial stage programs, with a strong understanding of the product lifecycle from development through to commercialization.
• Position may require domestic and international travel (up to 20%).

Knowledge and Skills

• Strong project management, organizational, and leadership skills with the ability to multitask and prioritize in a fast-paced environment.
• Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all levels of the organization.
• Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.
• Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office (Word, Excel, PowerPoint).
• Strategic thinking with a proactive approach to problem-solving and process improvement.
• Strong experienced with antibody drug conjugates and biologics manufacturing processes. Some experience with small molecule manufacturing processes, a plus.