Smithfield Foods · 1 day ago
Senior Quality Assurance Manager - BioScience
Cincinnati, OH
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSmithfield Foods is an American food company with a leading position in packaged meats and fresh pork products. They are seeking a Quality Assurance leader to ensure compliance with Good Manufacturing Practices and oversee the quality management systems for pharmaceutical and medical device manufacturing.
Food and BeverageHospitality
Responsibilities
Lead and manage the QA team to ensure full compliance with cGMP standards and adherence to internal SOPs
Provide strategic direction and decision-making on all quality-related matters, acting as a go-to leader during escalations
Champion a culture of quality-first thinking, driving operational excellence across departments
Collaborate in the design, development, and refinement of quality systems, procedures, and product processes
Drive continuous improvement initiatives across QA operations to streamline workflows and elevate product quality
Coordinate with Regulatory Affairs to assess the impact of critical change control activities on customer satisfaction and compliance
Ensure accurate recordkeeping, archival, and retrieval of all QA-related data, supporting traceability and audit-readiness
Compile and present quality metrics and key performance indicators (KPIs) to senior management for informed decision-making
Assist in preparation and presentation of the Annual Product Review to the Quality Review Board
Maintain the facility in a constant state of readiness for FDA, EU, and other regulatory inspections
Actively participate in internal audits, customer audits, and regulatory inspections, demonstrating a deep understanding of applicable standards
Stay current with evolving FDA, EU, and ICH regulations, ensuring company procedures remain aligned with global expectations
Oversee and safeguard company Quality Management System (QMS) records to ensure accuracy, security, and compliance
Ensure timely and thorough investigations of OOS (Out of Specification) results, CAPAs, complaints, and deviations, all in accordance with FDA guidelines
Collaborate cross-functionally to support the validation of company processes, test methods, and computerized systems
Qualification
Required
Bachelor's degree from an accredited four-year college or university in a chemistry, microbiology or other relevant technical field and 8+ years of relevant manufacturing experience, or an equivalent combination of education and experience, required
Minimum 2 years of demonstrated experience in team management/development or project leadership is required preferably in pharmaceutical cGMP manufacturing
In-depth knowledge of relevant regulations and standards in the pharmaceutical industry (e.g., 21 CFR Part 210/211, ICH Q7, 21 CFR Part 11)
Strong understanding of Good Manufacturing Practices (GMP) and their application in the pharmaceutical industry
Experience in developing, implementing, and maintaining a quality management system
Experience in conducting internal and external audits and managing audit programs
Proficient with the TrackWise QMS modules for Quality Events, CAPA, OOS, and Audit (or equivalent eQMS system)
Familiarity with risk management principles and tools, including FMEA (Failure Modes and Effects Analysis) and risk assessment methodologies
Excellent analytical, problem-solving, and root cause analysis skills, with the ability to apply data-driven decision-making
Strong written and verbal communication skills, with the ability to effectively interact with cross-functional teams, regulatory authorities, and external stakeholders
Preferred
Candidates with a Master's Degree in a Science or Technical field from an accredited four-year college or university and 6+ years relevant experience will be considered qualified
Relevant certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous
Benefits
Relocation Package Available
Company
Smithfield Foods
Smithfield Foods is an American food company with a leading position in packaged meats and fresh pork products.
10001+ employees
H1B Sponsorship
Smithfield Foods has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (2)
2022 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$454.11M2025-09-04Post Ipo Secondary· $454.11M
2025-01-28IPO
2013-05-29Acquired
Leadership Team
Shane Smith
President and Chief Executive Officer
Allyson Bouldon
Vice President, Chief Ethics and Compliance Officer
Recent News
2025-12-16
Smithfield Foods, Inc.
2025-11-25
Company data provided by crunchbase