Quality Assurance Manager

Quality Assurance Manager Overview

• The Quality Assurance Manager ensures GMP compliance for clinical packaging and labeling operations supporting investigational drug development programs.
• Collaborate with stakeholders to resolve quality issues and maintain inspection readiness for clinical supply activities.
• Provide oversight for clinical packaging and labeling processes conducted by Contract Manufacturing Organizations (CMOs).
• Ensure adherence to regulatory requirements, approved specifications, and company quality systems throughout the clinical supply lifecycle.
• Support documentation review, batch disposition, and risk-based decision-making to ensure patient safety and product quality.
• Drive process improvements and quality excellence across internal and external stakeholders.
• Collaborate with Clinical Supply Chain, Regulatory Affairs, and external partners to support timely release of Investigational Medicinal Products (IMPs).
• Maintain current knowledge of GMP regulations and clinical trial requirements related to clinical packaging and labeling.

Quality Assurance Manager Key Responsibilities & Duties

• Provide GMP oversight for clinical packaging and labeling operations at external manufacturing facilities.
• Review and approve batch records, label proofs, and supporting documentation for clinical packaging and labeling activities.
• Ensure compliance with protocols, clinical trial requirements, and regulatory standards.
• Manage deviations, investigations, CAPAs, and change controls associated with clinical supply operations.
• Coordinate with stakeholders to resolve release issues and minimize disruptions to clinical trials.
• Evaluate temperature excursions and storage events affecting clinical trial materials.
• Support vendor qualification and ongoing oversight, including quality documentation review.
• Drive continuous improvement initiatives to enhance compliance and operational effectiveness.
• Maintain inspection readiness and support regulatory audits and internal inspections.

Quality Assurance Manager Job Requirements

• Bachelor's degree in a scientific discipline or pharmaceutical sciences required.
• Minimum of 5 years of experience in Pharmaceutical Quality Assurance or GMP-regulated functions.
• Demonstrated expertise in clinical packaging and labeling operations and documentation review.
• Experience managing deviations, investigations, CAPAs, and change controls.
• Strong knowledge of GMP requirements for Investigational Medicinal Products (IMPs) and clinical supply operations.
• Familiarity with electronic quality management systems and document management platforms.
• Excellent organizational, project management, and communication skills.
• Ability to make timely, scientifically justified, risk-based quality decisions.
• Experience supporting early-phase clinical development programs preferred.