Senior Director, GMP Quality Assurance

Position: Senior Director, GMP Quality Assurance

Department: Quality

Location: Remote USA

Status: Full-time Exempt

About Us

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.

Role Summary

As we expand and move toward clinical and commercial milestones, we are seeking a Senior Director to shape and lead our quality and compliance strategy and providing independent Quality oversight across its product portfolio and external GxP network. This role ensures that clinical and future commercial activities are conducted in accordance with applicable global regulations, cGxP requirements, regulatory commitments, and Company standards while supporting the Company’s strategic and operational objectives.

Operating within a fully outsourced model, the Senior Director provides executive Quality leadership for product disposition, external partner oversight, quality-system governance, regulatory inspections, and the identification and management of significant quality and compliance risks. The role has the authority to escalate quality concerns, reject product, and suspend regulated activities when necessary to protect patients, product quality, data integrity, or regulatory compliance.

Key Responsibilities

• Lead the development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system, including management review, document control, training, change control, deviations, investigations, CAPAs, complaints, and product-quality review.
• Provide independent Quality oversight of product manufacturing, testing, packaging, labeling, storage, and distribution activities performed by external partners.
• Serve as the Company’s final Quality authority for batch disposition and release within delegated responsibilities, while ensuring compliance with market-specific requirements, including Qualified Person certification where required.
• Ensure timely, risk-based review and approval of batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other records affecting product quality or disposition.
• Provide Quality oversight of process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes.
• Establish and maintain a risk-based lifecycle program for qualifying, auditing, monitoring, and requalifying CDMOs, contract laboratories, packagers, distributors, and other GxP suppliers.
• Establish quality agreements and governance processes that clearly define responsibilities, communication requirements, performance expectations, and escalation pathways with external partners.
• Monitor internal and external quality performance through meaningful metrics, management review, trend analysis, and partner governance; ensure significant risks and adverse trends are appropriately escalated and addressed.
• Lead regulatory inspection readiness and serve as the primary Quality representative during inspections and health-authority interactions. Oversee the development and completion of inspection responses and remediation commitments.
• Ensure appropriate oversight of data integrity, electronic records, computerized systems, and documentation practices within the Company and across its external GxP network.
• Lead or support critical quality events, including significant investigations, product-quality complaints, recalls, market actions, and regulatory notifications.
• Provide Quality expertise for business-development due diligence, licensing activities, product acquisitions, investigator-initiated studies, and promotional review, as applicable to the Company’s procedures and the role’s assigned scope.
• Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support required to meet portfolio and corporate objectives.
• Build and lead a high-performing Quality organization while fostering a culture of quality, accountability, compliance, transparency, and continuous improvement across the Company.