Quality Systems and Standards Manager-- BioScience

About the role

The Quality Systems and Standards Manager (QSS) position is crucial for maintaining the integrity of Smithfield BioScience, Inc.'s (SBC) quality management systems. Reporting to the Senior Quality Assurance Manager, this role ensures adherence to cGMP and regulatory guidelines, overseeing the manufacture of high-quality APIs and medical device components.

Responsibilities

• Maintain the Site Quality Management System (QMS) in compliance with all applicable regulations.
• Administer Site QMS governance through management reviews to ensure its suitability and effectiveness.
• Develop and use effective monitoring and controls for key QMS processes, such as deviations, change control, and CAPAs.
• Monitor Site quality systems performance using Key Quality Performance Indicators (KPI) Dashboard.
• Manage customer complaint handling processes for the site.
• Stay current with evolving FDA, EU, and ICH regulations, ensuring company procedures align with global expectations.
• Participate and manage the Site’s Quality Council as the process owner for Quality Planning and the QMS.
• Develop, oversee, and monitor the Site Quality Plan/Roadmap.
• Prepare and maintain the site Validation Master Plan in line with current requirements.
• Oversee the governance of Standard Operating Procedures (SOPs) sitewide.
• Maintain Technical Quality Agreement (TQA) templates for use with customers and suppliers.

Requirements

• Bachelor's degree from an accredited four-year college or university in an engineering, chemistry, microbiology, or other relevant technical field, with 5+ years of relevant manufacturing experience.
• Advanced experience in API pharmaceutical cGMP manufacturing is highly preferred.
• Proven leadership or project management experience, including team management/development or project leadership, with minimum 2 years of experience.
• In-depth knowledge of relevant regulations and standards in the pharmaceutical industry, including 21 CFR Part 210/211, ICH Q7, 21 CFR Part 11, and Good Manufacturing Practices (GMP).
• Experience with digital QMS tools (e.g., TrackWise) and strong understanding of data integrity principles (ALCOA+).
• Strong communication skills, analytical thinking, critical thinking, and cross-functional collaboration skills.

Skills & Competencies

• Experience with digital quality systems like TrackWise Digital or similar platforms.
• Experience in writing and editing technical documents.
• Familiarity with risk management principles and tools, including FMEA and risk assessment methodologies.
• Exceptional communicator with strong written and verbal communication skills, essential for audits, reporting, and cross-team collaboration.
• Bilingual communication in Mandarin and English is preferred.
• Certified Quality Manager (CQM), Certified Quality Auditor (CQA), or Six Sigma Black Belt are advantageous.

Pay

The expected pay range for this position is $105,000 - $140,000 annually. Smithfield Foods provides a comprehensive total rewards package, including a relocation package and competitive benefits.