Manager, Quality Assurance

Job Summary

Lead and manage all Quality Assurance activities to ensure compliance with GMP, GLP, regulatory, and customer requirements. Oversee quality systems, including deviations, CAPA, change control, complaints, audits, validation, qualification, and risk management. Review and approve quality documentation, batch releases, investigations, and vendor qualifications. Coordinate internal, customer, regulatory, and corporate audits, ensuring timely closure of observations. Drive continuous improvement through training, quality management reviews, regulatory compliance, and effective implementation of quality standards while ensuring EHS compliance across the site.

Key Responsibilities

• Ensure compliance with GMP, GLP, regulatory, and corporate quality requirements.
• Lead and manage quality systems, including deviations, CAPA, change control, OOS/OOT, complaints, validations, qualifications, and training.
• Review and approve quality documentation, investigations, validation/qualification reports, batch records, and product release decisions.
• Manage customer, regulatory, corporate, and vendor audits, including responses and compliance tracking.
• Oversee vendor qualification, quality agreements, and contract laboratory/manufacturer approvals.
• Conduct quality risk management, annual product quality reviews, internal audits, and management reviews.
• Monitor timely closure of quality events and drive continuous improvement initiatives.
• Provide GMP and quality-related training across the organization.
• Support regulatory compliance, documentation requirements, and EHS standards.
• Manage departmental resources, budgets, and quality improvement projects.