Quality Control Manager

AstraZeneca
United States
Workplace: OnsiteFull timeUSD 112,604.8 - 168,907.2 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: bachelorsSkills: ["Organizational","Collaboration","Communication","People leadership","Cross-functional coordination","Project management","Audit readiness"]

Lead Quality Control activities at the Alexion Georgia Manufacturing Facility in Bogart, overseeing QC operations, personnel, and budgets. Own QC strategy, inspection readiness, and compliance for microbiological and analytical testing, including oversight of contract laboratory testing. Manage method validation, risk assessments, environmental monitoring, and analytical transfers to support the CLO transgenic roadmap. Build and lead QC teams while driving continuous improvement and supporting investigations, CAPAs, and APQR processes.

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FursaFursa
AstraZeneca
AstraZeneca
3 days ago

Quality Control Manager

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Last checked: 1 hour agoStatus: Live

Job Summary

Lead Quality Control activities at the Alexion Georgia Manufacturing Facility in Bogart, overseeing QC operations, personnel, and budgets. Own QC strategy, inspection readiness, and compliance for microbiological and analytical testing, including oversight of contract laboratory testing. Manage method validation, risk assessments, environmental monitoring, and analytical transfers to support the CLO transgenic roadmap. Build and lead QC teams while driving continuous improvement and supporting investigations, CAPAs, and APQR processes.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Lead QC operations to ensure laboratory activities are compliant, efficient, and safe, applying testing, Lean, and safety standards.
  • •Manage QC laboratory teams and oversee laboratory scheduling and performance to meet regulatory, quality, and business requirements.
  • •Ensure validation and qualification of test methods and instruments for in-process and commercial release testing; represent QC during audits and regulatory interactions.
  • •Direct environmental monitoring and lead QC risk assessments with timely implementation of mitigation actions.
  • •Lead QC investigations support (LIR, deviations, CAPAs, and EM trend reports) and ensure timely testing completion and data approval to support batch disposition.

Pay and Benefits

Salary: USD 112,604.8 - 168,907.2 annually
Perks:Health InsuranceDentalVisionPaid LeaveRetirementEquity

Key Requirements

  • •10+ years of experience in a GMP laboratory.
  • •Build, mentor, and develop high-performing teams.
  • •Comprehensive knowledge of GMP/regulatory requirements related to stability, raw materials, and QC operations.
  • •Demonstrated people leadership and experience handling cross-functional teams in a matrix organization.
  • •Consistent record implementing Lean laboratory practices (e.g., 5S, visual management, paperless lab approaches) with strong project management and auditing experience.
Experience:10+ yearsBiotechPharmaceuticalBiopharmaceutical manufacturingGMPRegulated industryLaboratory testingQuality systems
Education:Bachelor's in biological sciences, chemical sciences, business, or similar technical field
Skills:OrganizationalCollaborationCommunicationPeople leadershipCross-functional coordinationProject managementAudit readiness
Tech Stack:GMPCGMPLean5SVisual managementPaperless labAI

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
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