Smithfield BioScience, Inc.
BioScience
QualitySystemsandStandardsManager
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“Quality Systems and Standards Manager at Smithfield BioScience, Inc.. Skills: Quality Systems, Quality Management System, cGMP, API manufacturing. Own the Quality Management System. Uphold process excellence”
What You'll Achieve.
Deliver products that meet the highest global standards; Ensure facility operates with unmatched precision and compliance
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, 5+ years of relevant manufacturing 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, 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, 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.
Own the Quality Management System
Uphold process excellence
Drive continuous improvement
Ensure operational readiness
Enforce current Good Manufacturing Practices (cGMP)
Safeguard quality management systems integrity
Oversee quality systems
Administer QMS governance
Develop monitoring controls
Monitor quality systems performance
Provide data integrity awareness
Manage customer complaint process
Monitor factors impacting QMS
Manage Quality Council
Identify compliance gaps
Develop Risk Register
Develop Site Quality Plan
Oversee SOP governance
Maintain Technical Quality Agreements
How You'll Work.
Team & Collaboration
Champion a culture of quality-first thinking; Drive Quality Excellence across departments; Cross-team collaboration
Communication Scope
Exceptional Communicator; Written communication skills; Verbal communication skills; Bilingual communication in Mandarin and English
Process & Methodology
Project management experience
Full Job Description
****If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub.**** A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We’re looking for motivated people who want to join our team and grow lasting and meaningful careers with us. **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 is important to our mission to deliver products that meet the highest global standards. As a**Quality Systems and Standards leader** , 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 the Quality Management System, uphold process excellence, and be a key driver of continuous improvement and operational readiness. If you're passionate about compliance, thrive in a fast-paced regulated environment, and are ready to lead with confidence—this is the opportunity for you. **WHAT YOU’LL DO:** _The below statements are intended to describe the general nature and level of work being performed by
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