Smithfield BioScience, Inc.
BioScience
SeniorQualityAssuranceManager
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“Senior Quality Assurance Manager at Smithfield BioScience, Inc.. Skills: Quality Assurance Leadership, Process Development & Continuous Improvement, Regulatory Compliance & Inspection Readiness. Lead and manage QA team. Ensure full compliance with cGMP standards”
What You'll Achieve.
ensure full compliance with cGMP standards; safeguarding the integrity of our quality management systems; manufacture of high-quality Active Pharmaceutical Ingredients (APIs); manufacture of medical device components; elevate product quality; ensure company procedures remain aligned with global expectations; ensure accuracy, security, and compliance of QMS records
Industry & Context.
Detail-Oriented Problem Solver; Analytical Thinker; problem-solving; root cause analysis; data-driven decision-making
What They're Looking For.
Must Have
8+ 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, understanding of Good Manufacturing Practices (GMP), 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), Excellent analytical, problem-solving, and root cause analysis skills, written and verbal communication skills
Nice to Have
Master’s Degree in a Science or Technical field and 6+ years relevant experience, Relevant certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt, Bilingual communication in Mandarin and English
What You'll Do.
Lead and manage QA team
Ensure full compliance with cGMP standards
Adherence to internal SOPs
Provide strategic direction
Decision-making on quality-related matters
Champion a culture of quality-first thinking
Drive operational excellence
Collaborate in design
refinement of quality systems
Coordinate with Regulatory Affairs
Assess impact of critical change control activities
Ensure accurate recordkeeping
Compile and present quality metrics
Assist in preparation of Annual Product Review
Maintain facility in constant state of readiness
Actively participate in internal audits
Actively participate in customer audits
Actively participate in regulatory inspections
Stay current with evolving FDA
Oversee and safeguard company Quality Management System (QMS) records
Ensure timely and thorough investigations of OOS results
Ensure timely and thorough investigations of CAPAs
Ensure timely and thorough investigations of deviations
Collaborate cross-functionally to support validation
How You'll Work.
Team & Collaboration
cross-functional coordination; cross-team collaboration; interact with cross-functional teams
Communication Scope
written and verbal communication skills; Exceptional Communicator; Strong Communicator; Bilingual communication in Mandarin and English
Process & Methodology
project leadership
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 Head of Quality** —a position that sits at the heart of our mission to deliver products that meet the highest global standards. As a **Quality Assurance 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 system controls, uphold procedural excellence, and be a key driver of continuous improvement and operational readi
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