Smithfield BioScience, Inc.
Bioscience
QualityAssuranceProjectsManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Assurance Projects Manager at Smithfield BioScience, Inc.. Skills: Quality Assurance, cGMP, TrackWise, Project Management. Ensure Site Quality Objectives are met. Maintain compliance with regulations”
What You'll Achieve.
Ensure Site Quality Objectives are met; Site remains in a state of compliance; Ensure that training records are maintained; Ensure that appropriate maintenance system tracking tools are in place; Ensure that periodic CSV assessments are completed; Provide governance for keeping supplier Quality Agreements up to date
Industry & Context.
Analytical Thinker; critical thinking; data-driven decision-making
What They're Looking For.
Must Have
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, 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), understanding of Good Manufacturing Practices (GMP) and their application in the pharmaceutical industry, Experience with digital QMS tools (e. g. , TrackWise), understanding of data integrity principles (ALCOA+), communication skills, analytical thinking, critical thinking, cross-functional collaboration skills
Nice to Have
Advanced experience in the API manufacturing, 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, Experience in API manufacturing, Certified Quality Manager (CQM), Certified Quality Auditor (CQA), Six Sigma Black Belt, Bilingual communication in Mandarin and English
What You'll Do.
Ensure Site Quality Objectives are met
Maintain compliance with regulations
Stewardship of Quality Culture
Oversee GMP documentation and systems
Manage GMP training program
Oversee Quality Engineering and CSV activities
Support site GMP supplier management
Oversee Trackwise Fit for Purpose and Use
Administer GMP training component
Ensure GMP training plans are in place
Oversee quality engineering aspects
Assure calibration and PM programs are up to date
Track/trending of critical process metrics
Ensure facilities are Fit for Purpose
Oversee computer system validation
Support inspection readiness actions
Provide direction for GMP supplier management
Maintain GMP approved supplier list
Direct annual review of supplier performance
Track and report on Quality Agreements status
How You'll Work.
Team & Collaboration
cross-team collaboration
Communication Scope
written communication skills; verbal communication skills; cross-functional collaboration skills
Process & Methodology
Project Management
Full Job Description
**If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.** Have a seat at our table. When you join Smithfield, you become part of something special – a company that's sustainably feeding people around the world, producing good food the right way with respect for our people, animals, communities and planet. With opportunities across locations and functions, a culture grounded in our Core Four values - gratitude, communication, respect and accountability - and a strong commitment to learning, collaboration, and innovation, Smithfield offers challenging and rewarding careers where you can grow, contribute and make a real impact. **Apply Now!** **THE VALUE YOU’LL BRING:** _The position summary states the general nature and purpose of the job. Overall accountabilities are defined in this section._ **Step Into a High-Impact Role in Quality Assurance!** Ready to make a real difference in the world of pharmaceutical and medical device manufacturing? Smithfield BioScience, Inc. (SBC) is seeking a quality-driven professional for **a full-time role reporting to the Senior Quality Assurance Manager —** a position that sits at the heart of our mission to deliver products that meet the highest global standards. As the**Quality Assurance Projects Manager** , you’ll be on the front lines of **enforcing current Good Manufacturing Practices (cGMP)** and safeguarding the **integrity of our quality management systems.** You won’t just be checking boxes—you’ll be shaping the standards that ensure our FDA-registered facility operates with unmatched precision and compliance. Your oversight will be critical to the **manufacture of high-quality Active Pharmaceutical Ingredients (APIs) and medical device components,** all in accordance with **21 CFR Parts 210/211, ICH Q7, ISO 22442, and EU regulatory guidelines**. You’ll own system controls, uphold procedural excellence, and be a key driver of continuous improvement and operatio
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