Quality Control Lab Manager

Lynch Regenerative Medicine, LLC; Franklin (TN); On-site; USD 110,000 - 140,000; Full time

Job summary

Lynch Regenerative Medicine, LLC seeks a Quality Control Manager to lead laboratory operations ensuring raw materials, in‑process samples, finished products meet cGMP and FDA/ICH guidelines. You will oversee testing, method transfers, validations, and investigations while guiding staff and coordinating with QA, Manufacturing, and Regulatory Affairs.

The role emphasizes leadership, regulatory experience, and the ability to drive quality improvements in a fast paced regulatory environment.

Qualifications

• Bachelor’s degree in a scientific field with 7+ years in pharmaceutical manufacturing or cGMP testing lab.
• Experience with FDA, ICH, cGMP, GLP/GMP and ISO13485 standards preferred.
• Proven leadership, mentorship, and team development能力.
• Experience with inspections, audits, regulatory agencies and CAPA processes.

Responsibilities

• Oversee lab operations, testing schedules, and release documentation for materials and products.
• Ensure compliance with FDA, cGMP, USP/EP standards; manage equipment qualification and data integrity.
• Direct method development, transfers, validations, and verifications per ICH guidelines.
• Lead investigations into OOS results, implement CAPA, and support regulatory audits.
• Hire, train, and mentor laboratory analysts; ensure training and safety compliance.

Skills

Analytical techniques (HPLC/GC)

Aseptic technique & mammalian cell use

Analytical method development/transfer

Leadership & mentorship

Cross-functional collaboration

Regulatory communications

Problem solving & critical thinking

Education

Bachelor’s degree in Chemistry, Pharmacy, Microbiology

Master’s degree preferred

Job description

The Quality Control Manager oversees and conducts laboratory operations to ensure raw materials, in-process samples, and finished cosmetic and drug/biologic products meet strict cGMP regulations. They manage testing schedules, validate analytical methods (HPLC, GC), lead staff, and ensure compliance with FDA or global ICH guidelines. As a part of their responsibilities, the QC Manager will perform routine procedures and analytical methods for lot release and stability testing of products, prepare technical reports and documentation, and perform technical evaluations of events to determine root cause or recommend corrective action. The manager regularly interfaces with manufacturing teams, regulatory affairs departments, and corporate Quality Assurance to maintain supply chains and support regulatory audits

DUTIES AND RESPONSIBILITIES

• Lab Operations: Manage the daily scheduling, sample testing, and release documentation for raw materials, in process formulations, commercial products, and stability studies using a variety of test methods.
• Compliance & Quality: Ensure testing operations comply with FDA, cGMP, and USP/EP standards. Oversee equipment qualifications and laboratory data integrity.
• Method Developmen t: Oversee internal and external analytical method transfers, validations, and verifications according to ICH guidelines.
• Investigations: Lead root-cause investigations into Out-of-Specification (OOS) results, implement CAPA plans, and approve deviation reports. Assist Quality Assurance and Product Development/Manufacturing teams with investigations of non-conforming test results and products
• Team Leadership: Hire, train, and mentor laboratory analysts. Ensure all staff meet ongoing training, compliance, and safety requirements.

SKILLS & QUALIFICATIONS

• Deep understanding of analytical techniques such as HPLC/GC and spectrophotometry.
• Experience with aseptic technique and mammalian cell cultures and development/conduct of cell-based bioassays.
• Experience in development/transfer, qualification, and validation of analytical assays in a regulated environment (FDA, ICH, cGMP).
• Demonstrated leadership and mentorship of junior laboratory personnel, including training and career development.
• Ability to work well in a cross-functional team environment as well as independently.
• Excellent verbal and written communication skills.
• Experience with inspections, audits, and regulatory agencies/governing bodies.
• Exceptional critical thinking, problem-solving, and communication skills to navigate complex quality concerns.

PREFERRED QUALIFICATIONS

• Minimum of a Bachelor’s degree in Chemistry, Pharmacy, Microbiology, or a closely related scientific field, with 7 years of progressive experience in a pharmaceutical manufacturing or cGMP testing lab, including supervisory or management experience. Master’s degree in biology, biochemistry, Microbiology, or chemistry preferred.
• Knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations required
• Experience maintaining qualified laboratory equipment and creating/reviewing technical documents for an FDA-regulated laboratory
• Experience with the analysis of proteins
• Experience with the testing of cosmetic, drug, and biologic products throughout the development lifecycle.