Senior Quality Assurance Manager - BioScience

Smithfield Foods
Cincinnati
Workplace: OnsiteFull timeUSD 120,000 - 162,500 annuallyFunction: QA, Test & Release EngineeringExperience: 8+ yearsEducation: bachelorsSkills: ["Leadership","Communication","Problem-solving","Analytical thinking","Root cause analysis"]

Lead and manage the QA team for pharmaceutical and medical device manufacturing, ensuring full compliance with cGMP, SOPs, and global regulatory standards. Drive quality system development and continuous improvement, oversee recordkeeping and investigations (OOS, CAPA, complaints, deviations), and maintain inspection readiness for FDA/EU audits. Manage QA reporting, including quality metrics and the Annual Product Review, and collaborate with Regulatory Affairs on critical change control.

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Smithfield Foods
Smithfield Foods
2 months ago

Senior Quality Assurance Manager - BioScience

✓ Verified Job

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Source: Company careers pageValidated by: Fursa AI
Last checked: 2 days agoStatus: Live

Job Summary

Lead and manage the QA team for pharmaceutical and medical device manufacturing, ensuring full compliance with cGMP, SOPs, and global regulatory standards. Drive quality system development and continuous improvement, oversee recordkeeping and investigations (OOS, CAPA, complaints, deviations), and maintain inspection readiness for FDA/EU audits. Manage QA reporting, including quality metrics and the Annual Product Review, and collaborate with Regulatory Affairs on critical change control.
Location: Cincinnati
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Manager level

Key Responsibilities

  • •Lead and manage the QA team to ensure compliance with cGMP standards and adherence to internal SOPs.
  • •Provide strategic direction on quality matters and act as a go-to leader during escalations.
  • •Collaborate on the design, development, and refinement of quality systems, procedures, and product processes, driving continuous improvement initiatives.
  • •Ensure accurate recordkeeping and retrieval, compile quality metrics and KPIs, and support the Annual Product Review.
  • •Maintain constant inspection readiness and oversee investigations for OOS, CAPA, complaints, and deviations while staying current with FDA/EU/ICH regulations.

Pay and Benefits

Salary: USD 120,000 - 162,500 annually
Perks:Relocation

Key Requirements

  • •Bachelor’s degree in chemistry, microbiology, or a relevant technical field plus 8+ years of relevant manufacturing experience (or an equivalent combination).
  • •Minimum 2 years of experience in team management/development or project leadership, preferably in pharmaceutical cGMP manufacturing.
  • •In-depth knowledge of pharmaceutical regulations and standards including 21 CFR Part 210/211, ICH Q7, and 21 CFR Part 11.
  • •Experience developing, implementing, and maintaining a quality management system, including internal and external audit program management.
  • •Proficiency with TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system).
Experience:8+ yearsPharmaceuticalMedical deviceCGMP manufacturing
Education:Bachelor's in chemistry, microbiology or other relevant technical field
Skills:LeadershipCommunicationProblem-solvingAnalytical thinkingRoot cause analysis
Certifications:Certified Quality Manager (CQM)Certified Quality Auditor (CQA)Six Sigma Black Belt
Languages:MandarinEnglish
Tech Stack:CGMPSOPsTrackWise DigitalTrackWise QMSEQMSComputerized systems

Company Brief

Smithfield Foods
Produces pork and packaged meat products, operating integrated hog production, processing, and branded food businesses. It supplies retail, foodservice, and export markets across the United States and internationally.
Industry: Food Production
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Established Company
Headquarters: Smithfield, United States
Founded: 1936
WebsiteLinkedIn