Director/Senior Director GMP Quality
Verastem Oncology
June 29, 2026
Remote friendly (Greater Boston)
United States
Operations
Responsibilities:
- Support the Head of Quality with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements.
- Help define and drive the Quality vision and mindset.
- Define Quality objectives; drive progress, cross-functional completion, and risk analysis/mitigation.
- Partner with Quality, Technical Operations, Supply Chain, and CMO sites to meet timelines and execute technical transfers.
- Review batch records and analytical data for conformance; disposition clinical-stage batches for human use timely.
- Ensure effective change management for changes impacting GMP drug substance/product/finished goods and other GMP processes.
- Review and approve external product technical investigations and deviations.
- Interface with Technical Operations (CMC), Supply Chain, Clinical Operations, and Regulatory Affairs to resolve activities and support continuous improvement.
- Develop and approve SOPs; ensure control over quality vendor services and products.
- Lead cross-functional committees for specifications/materials review (Specification Review Committee, Material Review Board).
- Support validation and implementation of electronic Quality Systems (e.g., Veeva QualityDocs, Veeva QMS, LMS).
- Develop Quality plans/metrics for QMS effectiveness and report via management review.
- Maintain knowledge of industry trends/standards for cGMPs; review regulatory filings/technical documents.
- Participate in pre-approval and routine regulatory agency inspections; visit CMO sites as required.
- Other responsibilities as assigned.
Qualifications:
- Bachelor’s degree in a scientific field; advanced degree preferred.
- 15+ years of Quality Assurance/Manufacturing Operations experience in pharma/biotech.
- In-depth GMP/QA knowledge; thorough understanding of FDA, EMA, and ICH quality regulations.
- Excellent attention to detail.
- Customer-service mindset; solution oriented; effective in lean/flexible organizations.
- Experience with Regulatory/Health Authority Inspections.
- Excellent verbal and written communication skills.
Benefits/Compensation:
- Base salary range: $190,000–$270,000; eligible for annual bonus, equity compensation, and competitive benefits package.
- Support the Head of Quality with oversight of Verastem Quality Systems and QA activities in accordance with GXP requirements.
- Help define and drive the Quality vision and mindset.
- Define Quality objectives; drive progress, cross-functional completion, and risk analysis/mitigation.
- Partner with Quality, Technical Operations, Supply Chain, and CMO sites to meet timelines and execute technical transfers.
- Review batch records and analytical data for conformance; disposition clinical-stage batches for human use timely.
- Ensure effective change management for changes impacting GMP drug substance/product/finished goods and other GMP processes.
- Review and approve external product technical investigations and deviations.
- Interface with Technical Operations (CMC), Supply Chain, Clinical Operations, and Regulatory Affairs to resolve activities and support continuous improvement.
- Develop and approve SOPs; ensure control over quality vendor services and products.
- Lead cross-functional committees for specifications/materials review (Specification Review Committee, Material Review Board).
- Support validation and implementation of electronic Quality Systems (e.g., Veeva QualityDocs, Veeva QMS, LMS).
- Develop Quality plans/metrics for QMS effectiveness and report via management review.
- Maintain knowledge of industry trends/standards for cGMPs; review regulatory filings/technical documents.
- Participate in pre-approval and routine regulatory agency inspections; visit CMO sites as required.
- Other responsibilities as assigned.
Qualifications:
- Bachelor’s degree in a scientific field; advanced degree preferred.
- 15+ years of Quality Assurance/Manufacturing Operations experience in pharma/biotech.
- In-depth GMP/QA knowledge; thorough understanding of FDA, EMA, and ICH quality regulations.
- Excellent attention to detail.
- Customer-service mindset; solution oriented; effective in lean/flexible organizations.
- Experience with Regulatory/Health Authority Inspections.
- Excellent verbal and written communication skills.
Benefits/Compensation:
- Base salary range: $190,000–$270,000; eligible for annual bonus, equity compensation, and competitive benefits package.