Smithfield Foods

3 weeks ago

Quality Systems and Standards Manager-- BioScience

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Lead the Quality Management System for a pharmaceutical and medical device manufacturing site, enforcing current cGMP and ensuring compliance for API and device component manufacturing. Own QMS governance, continuous improvement, and quality planning activities through Quality Council and the quality roadmap, including risk management and validation planning. Oversee SOP governance and quality agreements, monitor quality KPIs, and drive data integrity and complaint management while coaching and mentoring the QA team.

Location: Cincinnati

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Own the Quality Management System (QMS) as Site Owner, ensuring systems, SOPs, and tools are in place and properly maintained.
•Maintain QMS compliance through governance (management reviews), process monitoring/controls (deviations, Change Control, CAPAs), and quality KPI tracking.
•Drive continuous improvement via the Site Quality Council and administer the Site Quality Road Map and Quality Plan.
•Manage quality planning and validation activities, including compliance risk management (Risk Register) and preparation/maintenance of the Validation Master Plan.
•Oversee sitewide SOP governance and maintain Technical Quality Agreement (TQA) templates; provide data integrity awareness/training and manage customer complaint handling.

Pay and Benefits

Salary: USD 105,000 - 140,000 annually

Perks:Relocation

Key Requirements

•Bachelor's degree in an engineering/chemistry/microbiology or other relevant technical field plus 5+ years of relevant manufacturing experience (or equivalent).
•2+ years of proven leadership or project management experience, preferably in API pharmaceutical cGMP manufacturing.
•Master's degree in a science or technical field plus 3+ years in pharmaceutical cGMP manufacturing (as an alternative qualification).
•In-depth knowledge of pharmaceutical regulations and standards, including 21 CFR Parts 210/211 and ICH Q7 (plus 21 CFR Part 11).
•Strong understanding of GMP and data integrity principles (ALCOA+), with experience using digital QMS tools such as TrackWise; risk management knowledge is preferred.

Experience:5+ yearsPharmaceutical manufacturingMedical devicesAPI manufacturingCGMP

Education:Bachelor's in Engineering, chemistry, microbiology or other relevant technical field

Skills:LeadershipCoachingCommunicationAnalytical thinkingCross-functional collaboration

Certifications:Certified Quality Manager (CQM)Certified Quality Auditor (CQA)Six Sigma Black Belt

Languages:MandarinEnglish

Tech Stack:CGMP21 CFR Part 21021 CFR Part 211ICH Q721 CFR Part 11ISO 22442EU regulationsTrackWise DigitalQMSCAPADeviationsChange ControlKPI DashboardALCOA+FMEARisk assessment methodologiesSOPsTechnical Quality Agreements (TQA)Quality CouncilRisk Register

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

Website LinkedIn

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Smithfield Foods

3 weeks ago

Quality Systems and Standards Manager-- BioScience

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: Cincinnati

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Own the Quality Management System (QMS) as Site Owner, ensuring systems, SOPs, and tools are in place and properly maintained.
•Maintain QMS compliance through governance (management reviews), process monitoring/controls (deviations, Change Control, CAPAs), and quality KPI tracking.
•Drive continuous improvement via the Site Quality Council and administer the Site Quality Road Map and Quality Plan.
•Manage quality planning and validation activities, including compliance risk management (Risk Register) and preparation/maintenance of the Validation Master Plan.
•Oversee sitewide SOP governance and maintain Technical Quality Agreement (TQA) templates; provide data integrity awareness/training and manage customer complaint handling.

Pay and Benefits

Salary: USD 105,000 - 140,000 annually

Perks:Relocation

Key Requirements

•Bachelor's degree in an engineering/chemistry/microbiology or other relevant technical field plus 5+ years of relevant manufacturing experience (or equivalent).
•2+ years of proven leadership or project management experience, preferably in API pharmaceutical cGMP manufacturing.
•Master's degree in a science or technical field plus 3+ years in pharmaceutical cGMP manufacturing (as an alternative qualification).
•In-depth knowledge of pharmaceutical regulations and standards, including 21 CFR Parts 210/211 and ICH Q7 (plus 21 CFR Part 11).
•Strong understanding of GMP and data integrity principles (ALCOA+), with experience using digital QMS tools such as TrackWise; risk management knowledge is preferred.

Experience:5+ yearsPharmaceutical manufacturingMedical devicesAPI manufacturingCGMP

Education:Bachelor's in Engineering, chemistry, microbiology or other relevant technical field

Skills:LeadershipCoachingCommunicationAnalytical thinkingCross-functional collaboration

Certifications:Certified Quality Manager (CQM)Certified Quality Auditor (CQA)Six Sigma Black Belt

Languages:MandarinEnglish

Company Brief

Smithfield Foods

Industry: Food Production

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Headquarters: Smithfield, United States

Founded: 1936

Website LinkedIn