Quality Release Manager

Accentuate Staffing; Raleigh (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive pay

Benefits package

Job summary

A leading recruitment agency is seeking a Quality Release Manager for a direct hire opportunity at a prominent pharmaceutical company in North Carolina. The candidate should possess over 10 years of experience in pharmaceutical quality assurance with a strong background in batch disposition within a cGMP environment. Responsibilities include leading the batch release review team and ensuring compliance with regulatory standards. This position offers competitive pay and benefits, working onsite.

Qualifications

• 10+ years of progressive pharmaceutical QA experience in a CGMP-regulated manufacturing environment.
• 5+ years of leadership experience in batch review and product release.
• Familiarity with quality systems and document management systems (eQMS).
• 5+ years of leadership experience overseeing batch record review, batch disposition, and product release activities
• Strong knowledge of CGMPs, GLPs, GDPs, and ALCOA+ data integrity principles
• Experience supporting regulatory inspections and interacting with agencies such as FDA or other global health authorities
• Proven experience reviewing deviations, investigations, and OOS results and familiarity with quality systems and document management systems (eQMS)
• Experience in sterile or aseptic manufacturing environments preferred
• SAP or similar ERP system experience preferred
• Lean, Six Sigma, or quality certifications (ASQ, Greenbelt, etc.) are a plus

Responsibilities

• Lead batch record review and final disposition of finished product batches.
• Oversee the batch release review team for compliant product release.
• Coordinate with cross-functional teams including Production, QC, and Regulatory.
• Perform QA functional review of deviations, exceptions, and OOS investigations, ensuring scientifically sound and compliant outcomes
• Maintain batch disposition records and report on key quality metrics, including release cycle times and KPIs
• Support regulatory inspections, customer audits, and internal audits as the subject matter expert for batch release processes
• Review and approve documentation supporting Annual Product Quality Reviews (APQRs)
• Provide leadership, coaching, and mentoring to QA staff involved in batch review and release activities

Skills

Leadership in pharmaceutical quality assurance

Batch disposition expertise

Experience in cGMP regulation

Knowledge of CGMPs, GLPs, GDPs

Ability to support regulatory inspections

Cross-functional coordination

Data integrity (ALCOA+)

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Tools

SAP or similar ERP system

eQMS

Job description

Accentuate Staffing is partnering with a leading pharmaceutical company who is hiring for a Quality Release Manager. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate has strong leadership experience in pharmaceutical quality assurance, deep expertise in batch disposition and release, and a proven ability to operate in a cGMP-regulated manufacturing environment.

Responsibilities

1. Lead batch record review and final disposition (approve, reject, hold) of finished product batches in compliance with regulatory requirements
2. Oversee and manage the batch release review team, ensuring timely, accurate, and compliant product release
3. Coordinate cross-functional activities with Production, QC Chemistry, QC Microbiology, QA Investigations, Supply Chain, and Regulatory teams
4. Perform QA functional review of deviations, exceptions, and OOS investigations, ensuring scientifically sound and compliant outcomes
5. Maintain batch disposition records and report on key quality metrics, including release cycle times and KPIs
6. Support regulatory inspections, customer audits, and internal audits as the subject matter expert for batch release processes
7. Review and approve documentation supporting Annual Product Quality Reviews (APQRs)
8. Provide leadership, coaching, and mentoring to QA staff involved in batch review and release activities

Requirements

1. Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, or related life science
2. 10+ years of progressive pharmaceutical QA experience in a CGMP-regulated manufacturing environment
3. 5+ years of leadership experience overseeing batch record review, batch disposition, and product release activities
4. Strong knowledge of CGMPs, GLPs, GDPs, and ALCOA+ data integrity principles
5. Experience supporting regulatory inspections and interacting with agencies such as FDA or other global health authorities
6. Proven experience reviewing deviations, investigations, and OOS results and familiarity with quality systems and document management systems (eQMS)
7. Experience in sterile or aseptic manufacturing environments preferred
8. SAP or similar ERP system experience preferred
9. Lean, Six Sigma, or quality certifications (ASQ, Greenbelt, etc.) are a plus