Senior Quality Control Manager - BioScience

Overview

We are seeking a full-time Quality Control Leader to report to the Head of Quality. In this key leadership role, you will oversee QC operations, champion cGMP compliance, and drive quality excellence across laboratory testing of APIs and medical device components.

• Quality Control Leadership – Ensure accurate testing, prompt reporting, and regulatory compliance. Provide hands-on leadership for laboratory decision-making.
• Cross Functional Collaboration – Serve as QC voice in cross-functional discussions with QA and Production, inform site management of critical lab needs.
• Regulatory & Compliance Readiness – Maintain inspection readiness, support FDA and other inspections, report deviations and OOS to QA, assist in raw material and finished good testing.
• Process Optimization & Continuous Improvement – Monitor and report key quality metrics, use data to support improvement, review and update lab SOPs.
• Method Development & Validation – Develop and validate new laboratory methods and support computer system validations through protocols, study execution, and reporting.
• Training & Equipment Oversight – Manage lab equipment usage, maintenance, and training of QC analysts and managers on methods and instrumentation.

• Bachelor's degree in chemistry, microbiology, or other relevant technical field; 8+ years of FDA cGMP QC experience.
• 2+ years of team management or project leadership.
• Master's degree and 6+ years of relevant experience also acceptable.
• Proficient with analytical technologies such as HPLC, FTIR, ICP, AA, and UV/VIS spectrophotometers.
• Excellent written and verbal communication, strong analytical and problem solving skills.
• Team player capable of working under high pressure and managing multiple priorities.
• Bilingual communication in Mandarin and English preferred.
• Proficient in technical writing and complex mathematical calculations.

Salary Range: $117,000 - $175,125. Relocation Package Available:
Yes.

Benefit plans and programs support medical, dental, vision, and wellness. Be Well programs include resources for weight loss, mental health, and more. Professional development, tuition assistance, leadership development and scholarship programs are offered.

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 veteran status, status as a disabled individual or any other protected group status or non-journal characteristic as directed by law. If an applicant has a disability and requires a reasonable accommodation, please call .