Quality Assurance Operations Manager Bioscience

Position: Quality Assurance Operations Manager - (Bioscience)
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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.

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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 Bio Science, 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…