Quality Assurance Manager

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

• Demonstrate strong knowledge of cGMPs, applicable GxPs, and pharmaceutical distribution processes.
• Perform routine quality audits of CMOs, including follow-up and timely closure of CAPA actions.
• Establish and maintain quality standards aligned with current regulatory requirements and PCC management expectations.
• Ensure implementation of the Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations across External Supply and satellite Quality operations.
• Lead and/or support meetings with external manufacturing organizations to review manufacturing status, complaints, and non-conformances.
• Manage internal and external change controls, including impact assessments and approvals.
• Coordinate technically with cross-functional teams to expedite resolution of complaints, deviations, change controls, and investigations.
• Prepare, review, and maintain quality documentation, including Quality Agreements.
• Manage non-conformance and complaint investigations at external sites, including initiation and tracking within internal systems.
• Support changes to specifications, processes, or procedures at external sites, including initiation of internal tracking documents, assignment of action items, and project closure.
• Provide final product disposition, including review of externally generated batch records and analytical testing results.
• Manage stability programs for externally manufactured products, including review and evaluation of stability data.
• Review and/or approve Annual Product Quality Review (APQR) documents for externally manufactured products and support Regulatory Affairs with Annual Reports.
• Conduct internal audits and participate in regulatory audit preparation, including CAPA development and ensuring timely CAPA closure.
• Review and approve artwork and labeling, ensuring only current, approved versions are used.
• Lead supplier qualification and approval, including audit planning, execution, documentation, and tracking of audit findings to closure.
• Support CMOs and internal functions (Supply Chain, Technical Operations, Regulatory Affairs) in process validation, API qualification, and related activities.
• Support Business Development and Sales for product launches in new markets by ensuring timely quality deliverables and effective CMO communication.
• Represent Quality Assurance in CMO-related projects, including technology transfers, providing guidance on quality requirements and reviewing transfer protocols and reports.
• Support CMO Quality Operations activities, including SOP development, document management, training, and implementation.
• Contribute to new quality initiatives and support development of long-term quality strategy.

Requirements

• 10-12 years working experience in a regulated Pharmaceutical Company in GMP environment
• Hands on experience of quality systems in a GxP environment, and direct experience with USFDA and other health authority inspections

A minimum of (3) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products