Quality Systems and Standards Manager-- BioScience

Job Summary

We are seeking a Quality Systems and Standards Manager to report to the Senior Quality Assurance Manager at Smithfield Bio Science, Inc. (SBC). The role will lead the enforcement of current Good Manufacturing Practices (cGMP) and uphold the integrity of our quality management system.

• Serve as the Site Owner of the Quality Management System (QMS).
• Maintain and ensure proper implementation of Systems, SOPs, and tools.
• Lead continuous improvement activities and administer the Site Quality Road Map through the Site Quality Council.
• Champion a culture of quality‑first thinking across the QA function and the site, promoting a Learning Organization.
• Provide coaching and feedback to enhance the QA team’s professional performance.
• Maintain QMS governance, including management reviews to ensure suitability and effectiveness.
• Develop monitoring and controls for key QMS processes such as deviations, change control, and CAPAs.
• Monitor performance through Key Quality Performance Indicators (KPIs) in a dashboard.
• Deliver annual data integrity awareness and training site‑wide.
• Manage customer complaint handling processes.
• Monitor internal and external factors impacting the QMS, staying current with FDA, EU, and ICH regulations.
• Own quality planning and validation master plans, including the Quality Council’s ownership and reviews.
• Maintain and govern Standard Operating Procedures (SOPs) site‑wide, ensuring relevance and completeness.
• Maintain Technical Quality Agreement (TQA) templates for customers and suppliers.

• Bachelor’s degree in engineering, chemistry, microbiology or a related technical field and 5+ years of relevant manufacturing experience, or equivalent education/experience; advanced experience in API manufacturing highly preferred.
• Minimum 2 years of proven leadership or project management experience in API pharmaceutical cGMP manufacturing.
• Master’s degree in a Science or Technical field; 3+ years in pharmaceutical cGMP manufacturing is considered qualified.
• In‑depth knowledge of regulatory standards such as 21 CFR Part 210/211, ICH Q7, and 21 CFR Part 11.
• Strong understanding of GMP application in the pharmaceutical industry; API manufacturing experience preferred.
• Experience with digital QMS tools (e.g., Track Wise).
• Knowledge of data integrity principles (ALCOA+).
• Strong communication, analytical, critical thinking, and cross‑functional collaboration skills.
• Certifications such as Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous.
• Bilingual communication in Mandarin and English is preferred.

Relocation Package:
No.

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, veteran status, disability, or any other protected group status as directed by law. If you have a disability and would like to request a reasonable accommodation, please call .