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Verastem Oncology

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

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive experience in Quality Assurance and Manufacturing Operations within the pharmaceutical or biotech industry, with a strong focus on GMP compliance, regulatory oversight, and the implementation of Quality Systems. Proven ability to collaborate cross-functionally and drive Quality objectives while maintaining effective communication with stakeholders.

Highest-signal resume keywords
Quality Assurance ExperienceGMP KnowledgeFDA Regulations UnderstandingRegulatory Inspection ExperienceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
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
Industry Keywords
Pharmaceutical IndustryBiotech IndustryGXP RequirementsEMA RegulationsICH StandardsRegulatory ComplianceHealth Authority Inspections

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