Senior Quality Assurance Manager, Pharma CDMO

Pace® Analytical Services; Lebanon (KY); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Competitive salary

Health, dental, and vision benefits

401(k) with company match

Paid time off and holidays

Professional development

Job summary

Pace® Life Sciences is seeking a Quality Assurance Manager in Lebanon, NJ to oversee the Quality Management System and ensure compliance with FDA, ICH, ISO, and cGMP. This full-time role leads QA activities across analytical testing operations, audits, investigations, and continuous improvement, partnering with operations to meet business needs.

The ideal candidate has 7+ years in QA within pharma/biotech/CDMO/Lab settings, plus 3+ years of leadership.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of Quality Assurance experience in a pharmaceutical, biotechnology, CDMO, or contract analytical laboratory environment.
• 3+ years of leadership or people management experience.
• Strong knowledge of deviations, CAPAs, change controls, and investigations.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) to ensure regulatory compliance.
• Provide QA oversight of analytical laboratory operations and GMP testing activities.
• Lead internal quality audits and client/regulatory inspections.
• Support regulatory filings and quality documentation as needed.

Skills

QA Management

cGMP knowledge

Regulatory compliance

QMS governance

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Tools

eQMS

Job description

Pace® Life Sciences is seeking a Quality Assurance Manager in Lebanon, NJ to oversee the Quality Management System and ensure compliance with FDA, ICH, ISO, and cGMP. This full-time role leads QA activities across analytical testing operations, audits, investigations, and continuous improvement, partnering with operations to meet business needs.

The ideal candidate has 7+ years in QA within pharma/biotech/CDMO/Lab settings, plus 3+ years of leadership.