The Site Quality Head provides strategic and operational leadership for all Quality functions across Manufacturing, Packaging, Importation, and Laboratory Operations. This role is accountable for fostering a strong quality culture, ensuring compliance with regulatory requirements, and maintaining the highest standards of product quality and patient safety.
Key responsibilities include oversight of quality systems and processes, including but not limited to:
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Development, implementation, and execution of quality procedures and standards
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Establishment Licensing compliance
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Quality on the Floor activities, audits, and batch disposition/release
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Management of laboratory investigations, deviations, complaints, and nonconformances
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CAPA development, implementation, and effectiveness monitoring
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Quality metrics, trending, and performance reporting
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Validation program compliance
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Oversight of equipment, facilities, and utility systems to ensure adherence to established quality requirements
The role is responsible for leading the development, standardization, implementation, monitoring, and continuous improvement of Quality Systems, compliance programs, industry best practices, and corporate quality initiatives. The successful candidate will drive proactive quality and compliance improvements while strengthening a culture of operational excellence and Good Manufacturing Practice (GMP) compliance.
This position also serves as the Senior Person In Charge (SPIC) for Controlled Drug Substances and Narcotics.
