Director/Senior Director, GMP Quality

Verastem Oncology

Director/Senior Director GMP Quality Assurance responsible for Quality Systems and compliance in biopharmaceutical operations. Overseeing Quality objectives, collaboration with teams, and validation of Quality Systems.

Posted 7/2/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $190,000 - $270,000 per yearWebsite

About the role

Key responsibilities & impact

Support the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements
Develop and implement procedures, policies, and systems to support commercial and clinical stage operations
Drive compliance with current regulations and oversight of external GMP Quality operations at partner and CMO sites
Help define and drive the Quality vision and mindset
Define clear Quality objectives and ensure cross-functional completion of responsibilities
Collaborate with Quality organization, Technical Operations, Supply Chain and CMO Sites
Review batch records and analytical data for conformance to specifications and regulations
Review and approve external product technical investigations and deviations
Actively support validation and implementation of new electronic Quality Systems

Requirements

What you’ll need

Bachelor’s degree in a scientific field; advanced degree preferred
Minimum of 15+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry
In-depth knowledge of GMP and QA principles, practices and standards
Through understanding of FDA, EMA and ICH quality regulations
Excellent verbal and written communication skills to effectively communicate with colleagues and vendors
Strong team player with a customer service approach and solution-oriented attitude
Works effectively and autonomously in a lean/flexible organization
Experience with Regulatory/Health Authority Inspections

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Systems DevelopmentGMP ComplianceQuality Objectives DefinitionBatch Record ReviewAnalytical Data ReviewTechnical Investigation ApprovalValidation of Electronic Quality Systems

Soft Skills

Excellent Communication SkillsTeam PlayerCustomer Service ApproachSolution-Oriented AttitudeAutonomous Work Style