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 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 Projects Manager Leadership

• Ensure 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 GMP documentation and systems (Trackwise) management.
• Manage the site GMP training program
• Oversee the Quality Engineering and CSV activities.
• Support site GMP supplier management activities.

Document Management and Trackwise

• Document Management: Maintain the GMP library and document storage for the site.
• Trackwise: Oversee the Fit for Purpose and Use of Trackwise by the site. Responsible for the site SME for Trackwise.
• Training: Administer the site GMP training component. Ensure that training records are maintained in Trackwise and are retrievable.
• Training Plans: Ensure that GMP training plans are in place / in use for all members at the site. Training plans are to be role specific.

Quality Engineering / CSV

• Quality Engineering: Oversee all aspects of quality engineering - change controls, GMP systems (purified water, HVAC), system drawings, and process / equipment modifications.
• Maintenance: Assure that calibration and PM programs are up to date and performing as designed. Ensure that appropriate maintenance system tracking tools are in place.
• Metrics: Track / trending of critical process metrics and ancillary support metrics (ie: EM Heat Maps, purified water quality)
• Fit for Purpose: Ensure that the facilities are Fit for Purpose through quality engineering assessments. Determine annual recapitalization budgets and planned shutdowns.
• CSV: Oversee the stewardship of computer system validation across the site including manufacturing and the QC Labs. See that periodic CSV assessments are completed.
• Inspection Readiness: Support the site's actions for being Inspection Ready. Create action plans for areas and systems needing remediation. Assist in developing / executing the tracking mechanism for Inspection Readiness.

Supplier Management

• Process Ownership: Provide direction for GMP supplier management as the process owner.
• Approved Supplier List: Maintain the site's GMP approved supplier list for materials and services.
• Periodic Review of Suppliers: Direct the annual review of supplier performance and stratification of suppliers based on criticality.
• Quality Agreements: Track and report on status of Quality Agreements. Provide governance for keeping supplier Quality Agreements up to date.

Skills & Competencies

• Knowledge / Expertise in Pharmaceutical Manufacturing Processes.
• Familiarity working with external suppliers and service providers.
• Tech Proficiency - Experience with digital quality systems like TrackWise Digital or similar platforms as well as maintenance systems like Blue Mountain.
• Fluency in creating and using metrics to drive results
• General understanding of CSV / GAMP 5.
• Coach and mentoring - enhance the skills of the QA staff and Production Operations for GMP fluency. Good Communicator - Strong written and verbal communication skills, essential for working with external parties and cross-team collaboration.
• 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.

Salary Range:

$96,000-$144,000
Relocation Package AvailableNo