Senior Director, GMP Quality Assurance

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $250k - $320k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• Lead development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system • Provide independent Quality oversight of manufacturing, testing, packaging, labeling, storage, and distribution performed by external partners • Serve as final Quality authority for batch disposition and release within delegated responsibilities • Review and approve batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other product-quality records • Oversee process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes • Establish and maintain risk-based qualification, auditing, monitoring, and requalification programs for GxP suppliers • Establish quality agreements and governance processes with external partners • Monitor quality performance through metrics, management review, trend analysis, and partner governance • Lead regulatory inspection readiness and serve as primary Quality representative during inspections and health-authority interactions • Oversee inspection responses and remediation commitments • Ensure oversight of data integrity, electronic records, computerized systems, and documentation practices • Lead or support critical quality events, investigations, complaints, recalls, market actions, and regulatory notifications • Provide Quality expertise for business-development due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review • Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support • Build and lead a high-performing Quality organization and foster a culture of quality, accountability, compliance, transparency, and continuous improvement

🎯 Requirements

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline • Advanced degree preferred • At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology industry • Significant leadership responsibility for commercial products • Experience leading Quality in a fully or substantially outsourced operating model • Experience overseeing 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 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 leading regulatory inspections, responses, remediation activities, and compliance commitments • Ability to make independent, risk-based product-quality and compliance decisions using scientific and regulatory judgment • Experience leading managers and professional staff and establishing Quality governance across cross-functional and external-partner organizations • Strong executive presence and ability to communicate complex quality risks, recommendations, and decisions clearly • Excellent leadership, negotiation, organizational, analytical, and problem-solving skills • Ability to manage multiple priorities in a dynamic environment

🏖️ Benefits

• Discretionary annual bonus may be available based on individual and Company performance • Equal opportunity employer • Background screen required as a condition of employment