Quality Assurance Manager Leader

3 weeks ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Description
About the RoleLynkx Staffing LLC is seeking a highly skilled Quality Assurance Manager Leader to oversee and manage quality assurance validation/qualification activity at two Allendale, NJ manufacturing sites. As a key member of our team, you will be responsible for ensuring compliance with FDA and EMEA regulations, managing end-to-end delivery of quality documents, and coordinating investigation and closure of deviations.
Key Responsibilities
  • Develop, implement, and maintain quality assurance validation programs
  • Manage validation teams, providing leadership and direction to ensure organizational and departmental goals are met
  • Ensure compliance with regulatory requirements, including GMP and cGMP guidelines
  • Coordinate internal audits, health authority inspections, and client audits
  • Collaborate with cross-functional teams to support organizational strategy and continuous improvement initiatives

Requirements
  • Bachelor of Science in biological sciences or relevant field of study
  • 5-10 years' experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments
  • 3+ years of recent supervisory experience required
  • Knowledge of FDA and EMEA regulations, root cause analysis, and electronic applications for training, deviations, CAPA management

Salary and BenefitsThe estimated salary for this position is $120,000 - $150,000 per year, depending on experience. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

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