QA Manager, Finished Goods CommercialApply Now
Location: Boston, Massachusetts
Employment Type: Contract
Job Description
Title: QA Manager – Finished Goods Commercial
Location: Boston, MA
Work Arrangement: Hybrid
Employment Type: Contract
Duration: 12+ months
About the Role
We are seeking an experienced QA Manager – Finished Goods Commercial to support commercial product disposition, batch release, CMO quality oversight, investigations, change controls, and ongoing GMP compliance.
This role will work closely with external manufacturing partners and internal cross-functional teams to ensure commercial product quality, timely disposition, and continuity of supply across multiple markets.
Key Responsibilities
Key Skills
Commercial Quality Assurance | Batch Release | Finished Goods | GMP | GDP | CMO Quality Oversight | Batch Record Review | Deviations | OOS/OOT | CAPA | Change Control | Root Cause Analysis | Product Disposition
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $75.00–$82.00/hr, based on experience and qualifications.
Location: Boston, MA
Work Arrangement: Hybrid
Employment Type: Contract
Duration: 12+ months
About the Role
We are seeking an experienced QA Manager – Finished Goods Commercial to support commercial product disposition, batch release, CMO quality oversight, investigations, change controls, and ongoing GMP compliance.
This role will work closely with external manufacturing partners and internal cross-functional teams to ensure commercial product quality, timely disposition, and continuity of supply across multiple markets.
Key Responsibilities
- Support disposition and batch release activities for finished commercial products
- Review executed batch records for commercial packaging operations and resolve documentation issues with CMOs
- Evaluate investigations, OOS events, OOT events, and change controls to determine product impact and disposition status
- Review change controls against lot genealogy and regional requirements to support compliant release decisions
- Provide quality guidance for root-cause analysis, product impact assessments, and CAPA development
- Lead Quality-to-Quality meetings with CMOs and drive timely completion of release and quality activities
- Support quality agreements, CMO performance metrics, audit preparation, inspection support, and post-inspection activities
- Bachelor's degree in a scientific or allied health field
- 4+ years of relevant Quality Assurance experience, or an equivalent combination of education and experience
- Strong experience with commercial GMP quality operations
- Experience supporting batch disposition and product release
- Experience reviewing batch records, deviations, investigations, OOS/OOT events, change controls, and CAPAs
- Strong understanding of GMP/GDP regulations and risk-based quality decision-making
- Ability to work independently and manage multiple complex quality activities
- Strong communication, influencing, and cross-functional collaboration skills
- Experience supporting finished goods and commercial oral drug products
- Experience managing quality relationships with CMOs
- Strong knowledge of global GMP requirements and commercial manufacturing practices
- Broad GxP knowledge across the product lifecycle
- Experience with Root Cause Analysis methodologies
- Experience supporting audits and regulatory inspections
- Project management and continuous improvement experience
- Ability to lead cross-functional teams and represent Quality in complex business discussions
Key Skills
Commercial Quality Assurance | Batch Release | Finished Goods | GMP | GDP | CMO Quality Oversight | Batch Record Review | Deviations | OOS/OOT | CAPA | Change Control | Root Cause Analysis | Product Disposition
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $75.00–$82.00/hr, based on experience and qualifications.
Contact
Ovrille Gonsalves
Director of Recruiting & Training
Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.
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