Senior QA Manager | cGMP & External Supply Quality

Germer International - Pharmaceutical Recruiting; Allentown (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading Pharmaceutical Recruiting firm seeks a Quality Assurance Specialist to oversee quality operations within a regulated environment. The ideal candidate will have over 10 years of experience in GMP, hands-on quality system management, and oversight of sterile pharmaceutical products. Responsibilities include managing quality audits, supporting regulatory compliance, and leading non-conformance investigations. This role focuses on ensuring the highest standards of quality and compliance in pharmaceutical manufacturing.

Qualifications

• 10-12 years of experience in a regulated Pharmaceutical Company in a GMP environment.
• Hands-on experience with quality systems in a GxP environment.
• Direct experience with USFDA and other health authority inspections.
• 3+ years of overseeing quality operations for sterile pharmaceutical products.

Responsibilities

• Manage routine quality audits of CMOs and CAPA actions.
• Establish quality standards aligned with regulatory requirements.
• Lead meetings with external manufacturing organizations.
• Manage non-conformance and complaint investigations.
• Support CMO Quality Operations activities.

Skills

Knowledge of cGMPs and GxPs

Quality audits

Regulatory compliance

Change control management

Complaint investigation

Job description

A leading Pharmaceutical Recruiting firm seeks a Quality Assurance Specialist to oversee quality operations within a regulated environment. The ideal candidate will have over 10 years of experience in GMP, hands-on quality system management, and oversight of sterile pharmaceutical products. Responsibilities include managing quality audits, supporting regulatory compliance, and leading non-conformance investigations. This role focuses on ensuring the highest standards of quality and compliance in pharmaceutical manufacturing.