Sr. Manager, Quality Assurance - Costa Mesa, CA Job at Hydrogen Group, Costa Mesa, CA

emJhYVowQWZEV0wxczBsL2hmdk9VNW9sY0E9PQ==
  • Hydrogen Group
  • Costa Mesa, CA

Job Description

Senior Manager, Quality Assurance

Our client, a growing pharmaceutical and biologics manufacturer, is looking to hire an experienced Senior Manager of Quality Assurance. This person would oversee QA operations supporting analytical and microbiology labs, ensuring cGMP compliance and operational efficiency across quality systems and laboratory testing processes. This opportunity is offered on a full-time and permanent basis, and is based onsite in Costa Mesa, CA.

Base salary: $120-140,000/year.

Key Responsibilities:

  • Lead and develop QA staff supporting QC and microbiology labs
  • Oversee batch record review, product release, change control, deviations, CAPAs, and annual product reviews
  • Drive compliance across QC operations, ensuring data integrity and adherence to regulatory standards
  • Partner cross-functionally with QC and manufacturing teams to meet timelines and customer needs
  • Support and present during external audits and regulatory inspections
  • Champion continuous improvement and implement LEAN initiatives in quality operations

What We're Looking For:

  • BS in a scientific or engineering discipline
  • 10+ years in QA within pharma, biotech, or biologics manufacturing
  • 5+ years overseeing QA functions in a QC lab environment
  • Strong leadership background (8+ years in supervisory or management roles)
  • Deep knowledge of cGMP regulations (US, EU, Canada, Japan)
  • Hands-on experience with quality systems including deviations, CAPAs, change control, and product release
  • Comfortable presenting to regulatory bodies and leading technical investigations
  • Certifications in ASQ, Green Belt, or Lean Six Sigma a plus

If interested, please apply with an up to date copy of your resume.

Job Tags

Permanent employment, Full time,

Similar Jobs

Prairie Band, LLC

Family Optometrist Job at Prairie Band, LLC

 ...You will be responsible for providing full-scope primary eye care independently delivering high-quality, comprehensive exams, diagnoses...  ...Details: MondayFriday, 8:00 AM 5:00 PM Adults and Pediatrics Full-time, up to a 1-year contract with possible extensions... 

R&D Partners

Research Associate (Antibody Discovery) Job at R&D Partners

 ...and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.... 

KPM LAW (Kalbaugh Pfund & Messersmith, P.C.)

Part-Time Remote/Hybrid Attorney - Workers' Compensation Claims (Virginia) Job at KPM LAW (Kalbaugh Pfund & Messersmith, P.C.)

 ...our team! We are seeking several dedicated Part-Time Remote/Hybrid Attorneys to assist with...  ...verbal communication skills. Ability to work independently and manage tasks in a...  ...organizational skills. Why Join Us? Work from home or a hybrid model for flexibility and... 

St. Vincent de Paul of Baltimore

Case Manager Job at St. Vincent de Paul of Baltimore

St. Vincent De Paul of Baltimore has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to SVDP...

UtilitiesOne

Traffic Control Manager Job at UtilitiesOne

 ...We are seeking an experienced Traffic Control Manager to oversee multi-state operations (WA/OR/ID/MT) , ensuring compliance with all regulatory requirements. The ideal candidate will have a background in managing traffic control teams, coordinating with municipalities...