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.

•  Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline; an advanced degree is preferred.
• At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology  industry, including significant leadership responsibility for commercial products.
• Demonstrated experience leading Quality in a fully or substantially outsourced operating model, with oversight of CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers.
• Broad experience across multiple product modalities and manufacturing platforms. Extensive experience with  batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product      complaints, and inspection readiness.
• Strong knowledge of applicable global  GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU      regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations.
• Experience interacting directly with regulatory authorities and successfully leading regulatory inspections, responses, remediation activities, and compliance commitments.
• Demonstrated ability to make independent, risk-based product-quality and compliance decisions using sound scientific and regulatory judgment.
• Experience leading managers and professional staff and establishing effective Quality governance across cross-functional and external-partner organizations.
• Strong executive presence and the  ability to communicate complex quality risks, recommendations, and  decisions clearly to senior leadership, boards, regulators, partners, and technical teams.
• Excellent leadership, negotiation, organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic environment.  

The expected salary range for this position is: $250k - $320k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.