Director, Quality Operations

Position Overview

The Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around commercialization of Varegacestat and continuing Varegacestat clinical programs. Additional projects will eventually be added. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development lifecycle and provide strategic quality leadership aligned with company objectives. Experience with small molecules and biologics is required.

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 clinical and 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

• A minimum of 10 years of experience in Quality Assurance and GMP compliance within a pharmaceutical or biotechnology environment, or equivalent.
• Extensive experience supporting outsourced manufacturing models, including oversight of CMOs and external service providers.
• Experience working with small molecules and biologics (ideally ADCs).
• Demonstrated senior-level experience leading global regulatory inspections and managing inspection outcomes.
• Significant experience supporting development-stage programs through commercial operations.
• Proven experience with internal and external audits, CAPA management, and continuous improvement initiatives.
• Ability to travel up to 20% to support audits and regulatory inspections, domestic and international.

Knowledge and Skills

• Deep technical knowledge of global GMP and GDP regulations, regulatory inspection expectations, and quality system requirements across development-stage and commercial operations.
• Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
• Strong understanding of quality systems, audit programs, CAPA management, recalls and risk-based compliance approaches in outsourced manufacturing environments.
• Proven ability to lead quality governance, management/quality review processes, and regulatory surveillance activities.
• Ability to assess, prioritize, and mitigate quality and compliance risks across CMOs, vendors, and internal operations.
• Strong leadership presence with the ability to effectively influence executive leadership and cross-functional stakeholders.
• Excellent verbal, written, interpersonal, and communication skills, with the ability to clearly convey complex quality and compliance topics.