Quality Assurance Operations Manager - (Bioscience)

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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 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 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 people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

Quality Assurance Manager Leadership

• Ensure all Site Quality Objectives are met and the Site remains in a state of compliance with all applicable regulations

• In supplying Quality oversight - the WHY as well as the HOW Quality is applied - is central to the role.

• Own the Stewardship of the Quality Culture within the QA Function as well as the Site. Promote the values of a Learning Organization.

• Oversee the review and approval of Manufacturing Batch Releases.

• Control the final release of Products to the Customer.

• Manage the oversight of Shop Floor Quality Assurance.

• Maintain all aspects of GMPs in the manufacturing areas as well as warehouse operations.

• Monitor all aspects of the Product Stability Program.

Shop Floor Quality Assurance

• Fit for Purpose: Maintain the facility in a constant state of readiness for FDA, EU, and other regulatory inspections.

• Observe: Provide real-time quality oversight of the manufacturing processes

• Documentation Review:administer review of batch production records and associated logs to ensure accuracy, data integrity (ALCOA+), and compliance

• Material and Equipment: verify raw material status (quarantine/approved) and ensure equipment calibration / PMs are current.

• Trained workforce: Verify that prescribed GMP training has taken place to qualify operations personnel for their tasks.

• Investigations: Administer the investigation process for all deviations or non-conformities. Ensure that adequate event intake has been completed and the event is properly leveled.

Batch Record Review / Approval

• Batch Approval: Oversee and approve completed batch records.

• Document Organization: Ensure all logs, batch records, training forms etc are organized and retrievable.

• Master Batch Records: Maintain the master batch records - keeping them up to date with modifications that occur via change controls / capas / improvement projects.

Environmental Monitoring (EM) / Product Stability Management

• EM schedule: Maintain activities associated with EM (air and water), coordinate / liase with QC Labs and Production to ensure all scheduled activities are kept.

• Stability Program: Working with QC Labs , maintain all stability sampling, testing, and reporting. Alert senior management in the event of any failures.

Quality Engineering

• Troubleshoot production issues to maintain compliance.

• PM/Calibration program oversight - process owner for Maintenance System (ie: Trackwise, Blue Mountain RAM)

• Oversee Quality by Design - including new equipment purchases. Oversee and Improve process automation capabilities.

• Manage site capital Projects - developing business case/budget and overseeing implementation.

• Improve product quality and efficiency via SPC and Lean Six Sigman processes.

Skills & Competencies

• Knowledge / Expertise in Pharmaceutical Manufacturing Processes.

• Experience with Quality Management Systems

• Understanding of manufacturing batch records and batch approval processes.

• Coach and mentoring - enhance the skills of the QA staff and Production Operations for GMP fluency.

• QMS & Tech Proficiency - Experience with digital quality systems like TrackWise Digital or similar platforms.

• Exceptional Communicator - Strong written and verbal communication skills, essential for audits, reporting, and cross-team collaboration. Bilingual communication in Mandarin and English is advantageous.

• Analytical Thinker - Brings logic, critical thinking, and data-driven decision-making to every challenge.

WHAT WE'RE SEEKING:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

• 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, required. Advanced experience in the API manufacturing is highly preferred.

• Proven leadership or project management experience: Minimum 2 years of demonstrated experience in team management/development or project leadership is required, preferably in API pharmaceutical cGMP manufacturing.

• 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.

• 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 API manufacturing is strongly preferred.

• 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.

• Preferred: Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous, Bilingual communication in Mandarin and English, etc.

EEO Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.