Quality Assurance Manager – Pharma CDMO Leader

RXinsider LTD.; Lebanon (NJ); Hybrid; USD 115,000 - 125,000; Full time

Benefits offered by this job

Competitive salary and annual bonus

Medical, dental, and vision benefits

401(k) with company match

Paid time off and holidays

Career growth opportunities

Collaborative work environment

Job summary

Pace® Life Sciences in New Jersey is seeking a Quality Assurance Manager to oversee the Quality Management System and ensure compliance with FDA, ICH, ISO, and cGMP requirements. You will lead QA activities across analytical testing, documentation review, and audits.

The ideal candidate has 7+ years in pharmaceutical QA, 3+ years of leadership, and hands-on experience with deviations, CAPAs, change controls, investigations, and data integrity practices.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 7+ years of Quality Assurance experience in pharmaceutical/biotech/CDMO environments.
• 3+ years of leadership or people management experience.
• Strong knowledge of FDA, cGMP, ICH, Data Integrity, and laboratory compliance.
• Experience documenting deviations, CAPAs, change controls, and investigations.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee and maintain the Quality Management System (QMS) and ensure regulatory compliance.
• Provide QA oversight of analytical testing operations and client programs.
• Review and approve analytical documentation, protocols, reports, and quality records.
• Support method validation, method transfer, stability studies, and development programs.
• Ensure ALCOA+ data integrity practices and regulatory expectations.
• Lead internal quality audits and inspection readiness; host client/regulatory audits.
• Manage audit findings and ensure timely corrective actions.
• Partner with clients on quality inquiries and regulatory filings; manage quality documentation.
• Lead and develop the QA team and drive continuous improvement.

Skills

QA leadership

Regulatory knowledge

Audit readiness

Data integrity

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences

Tools

eQMS

Job description

Pace® Life Sciences in New Jersey is seeking a Quality Assurance Manager to oversee the Quality Management System and ensure compliance with FDA, ICH, ISO, and cGMP requirements. You will lead QA activities across analytical testing, documentation review, and audits.

The ideal candidate has 7+ years in pharmaceutical QA, 3+ years of leadership, and hands-on experience with deviations, CAPAs, change controls, investigations, and data integrity practices.