Quality Release Manager Job at Accentuate Staffing, Raleigh, NC

OUxYcVVPTktFcldySnMwQlgxTXFOUTZmMGc9PQ==
  • Accentuate Staffing
  • Raleigh, NC

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

Job Tags

Similar Jobs

Houston Methodist

Security Officer nights Job at Houston Methodist

At Houston Methodist, the Security Officer position is responsible formaintaining a safe and secure environment for patients, staff and visitors by patrolling and monitoring hospital premises and personnel. This position provides assistance with personal protection, traffic... 

Merck & Co.

Chronic Care Specialty Sales Representative - Fresno Job at Merck & Co.

Job DescriptionAs a Chronic Care Specialty Sales Representative, you will drive meaningful patient impact by leveraging our scientific expertise and serving as the primary contact for customers within your assigned territory. As a key member of the local Customer Team,... 

Carle Health

Certified Child Life Specialist (CCLS) - Inpatient Pediatrics Job at Carle Health

Overview: The Child Life Specialist works to meet the psychosocial needs of patients and families by providing education, preparation, procedural support, and therapeutic play to reduce stress and enable pediatric patients to cope more effectively with their medical experiences... 

Centstone HC

RN - Psych Job at Centstone HC

 ...RN Psych Nights Lawton, OK Job Title: RN Psych Location: Lawton, Oklahoma Facility: Memorial Health System of Southwest...  ...at Memorial Health in Lawton, OK. This position supports psychiatric patient populations across adult, adolescent, pediatric, and geriatric... 

Bertera Chrysler Jeep Dodge Ram - West Springfield

Auto Body Shop Manager Job at Bertera Chrysler Jeep Dodge Ram - West Springfield

 ...Full Job Description Must be able to manage a fast paced shop. -Communicate -Communicate with customer on parts status. -Must have experience...  ...to upper management Requirements: - 2 year hands on body shop management experience - Ability to effectively multi-...