Quality Assurance Project Manager-Bioscience

Smithfield Foods • Cincinnati, OH

5d • Onsite

About The Position

Smithfield BioScience, Inc. (SBC) is seeking a quality-driven professional for a full-time role reporting to the Senior Quality Assurance Manager. This position is central to delivering products that meet the highest global standards. As the Quality Assurance Projects Manager, you will be responsible for enforcing current Good Manufacturing Practices (cGMP) and safeguarding the integrity of our quality management systems. Your role will ensure the FDA-registered facility operates with precision and compliance in the manufacture of high-quality Active Pharmaceutical Ingredients (APIs) and medical device components, in accordance with 21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU regulatory guidelines. You will own system controls, uphold procedural excellence, and drive continuous improvement and operational readiness. This role is for individuals passionate about compliance, thriving in a fast-paced regulated environment, and ready to lead with confidence.

Requirements

• Bachelor's degree from an accredited four-year college or university in an engineering, chemistry, microbiology or other relevant technical field and 5+ years of relevant manufacturing experience, or an equivalent combination of education and experience.
• Minimum 2 years of demonstrated experience in team management/development or project leadership, preferably in API 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 with digital QMS tools (e.g., TrackWise).
• Strong understanding of data integrity principles (ALCOA+).
• Strong communication skills, analytical thinking, critical thinking and cross-functional collaboration skills.

Nice To Haves

• Advanced experience in API manufacturing is highly preferred.
• Candidates with a Master’s Degree in a Science or Technical field from an accredited four-year college or university and 3+ years experience in pharmaceutical cGMP manufacturing will be considered qualified.
• Experience in API manufacturing is strongly preferred.
• Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous.
• Bilingual communication in Mandarin and English.

Responsibilities

• Ensure Site Quality Objectives are met and the Site remains in a state of compliance with all applicable regulations.
• Provide Quality oversight, explaining the WHY as well as the HOW Quality is applied.
• Own the Stewardship of the Quality Culture within the QA Function and the Site.
• Promote the values of a Learning Organization.
• Oversee GMP documentation and systems (Trackwise) management.
• Manage the site GMP training program.
• Oversee the Quality Engineering and CSV activities.
• Support site GMP supplier management activities.
• Maintain the GMP library and document storage for the site.
• Oversee the Fit for Purpose and Use of Trackwise by the site, acting as the site SME for Trackwise.
• Administer the site GMP training component, ensuring training records are maintained in Trackwise and are retrievable.
• Ensure GMP training plans are in place and in use for all members at the site, with plans being role-specific.
• Oversee all aspects of quality engineering, including change controls, GMP systems (purified water, HVAC), system drawings, and process/equipment modifications.
• Assure that calibration and PM programs are up to date and performing as designed, ensuring appropriate maintenance system tracking tools are in place.
• Track and trend critical process metrics and ancillary support metrics (e.g., EM Heat Maps, purified water quality).
• Ensure facilities are Fit for Purpose through quality engineering assessments and determine annual recapitalization budgets and planned shutdowns.
• Oversee the stewardship of computer system validation across the site, including manufacturing and QC Labs, and ensure periodic CSV assessments are completed.
• Support the site’s actions for being Inspection Ready, creating action plans for areas and systems needing remediation, and assisting in developing/executing the tracking mechanism for Inspection Readiness.
• Provide direction for GMP supplier management as the process owner.
• Maintain the site’s GMP approved supplier list for materials and services.
• Direct the annual review of supplier performance and stratification of suppliers based on criticality.
• Track and report on the status of Quality Agreements and provide governance for keeping supplier Quality Agreements up to date.

Benefits

• Relocation Package Available

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level