Head of Quality Assurance – GMP Lab

Fagron Nederland BV; Wichita (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with company match

Health savings account (HSA)

Medical, vision, dental insurance

Paid time off

Job summary

Fagron Analytical Services seeks a Quality Assurance Manager to establish and lead the on-site Quality Unit, owning the quality systems, data review, and disposition of laboratory testing. This role operates independently of bench testing and reports to the Quality Leader, FSS North America.

You will manage CAPA, change control, document control, and supplier qualifications, ensuring compliance with 21 CFR Part 11 and GDP standards across Chemistry and Microbiology operations.

Qualifications

• Bachelor’s degree in chemistry, biology, microbiology, or related field, required.
• Minimum 5 years of quality assurance in cGMP pharma/analytical lab environment.
• Knowledge of cGMP (21 CFR Parts 210 & 211) and 21 CFR Part 11.
• Ability to review laboratory data, investigations, and documents and approve/reject independently.
• Strong attention to detail and commitment to compliance with procedures.
• Ability to communicate with auditors, colleagues, and suppliers clearly.

Responsibilities

• Establish and maintain the Quality Management System (QMS) including SOPs and change control.
• Review and disposition laboratory results, worksheets, and COAs for Chemistry and Microbiology.
• Own investigation program (OOS/OOT, deviations, invalid assays) and close investigations.
• Lead CAPA processes: root cause, ownership, due dates, effectiveness checks.
• Own document control: issue/revise/obsolete/ archive SOPs and reports.
• Oversee method validation/verification and equipment qualification packages.

Skills

Quality leadership

Regulatory knowledge

Attention to detail

Data review

Communication

Education

Bachelor’s degree in chemistry/biology/microbiology

Advanced degree preferred

Tools

TEEXMA LIMS

Empower

Chromeleon

Document-control tools

Job description

Fagron Analytical Services seeks a Quality Assurance Manager to establish and lead the on-site Quality Unit, owning the quality systems, data review, and disposition of laboratory testing. This role operates independently of bench testing and reports to the Quality Leader, FSS North America.

You will manage CAPA, change control, document control, and supplier qualifications, ensuring compliance with 21 CFR Part 11 and GDP standards across Chemistry and Microbiology operations.