Senior Director, GMP Quality Assurance

Enliven Therapeutics

. Lead development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system .

Posted 10/13/2026full-timeRemote • United StatesSenior💰 $250,000 - $320,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmaceutical quality systems, regulatory compliance, and risk-based decision-making. Proven ability to lead quality oversight, manage external partnerships, and foster a culture of continuous improvement within a high-performing organization.

Highest-signal resume keywords

Pharmaceutical Quality SystemsRegulatory Inspection ReadinessGMP and GDP ComplianceBatch Disposition and ReleaseLeadership in Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality OversightChange ControlCAPA ManagementValidation OversightSupplier Quality ManagementAnalytical ReviewRisk-Based Decision MakingProcess ImprovementData Integrity ManagementQuality Metrics Analysis

Soft Skills

LeadershipNegotiationOrganizational SkillsAnalytical SkillsProblem-Solving

Industry Keywords

GxPCDMOFDAEMAICH Guidelines21 CFR Parts 210 and 211Pharmaceutical IndustryBiotechnology IndustryQuality GovernanceExternal Partner Management

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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