Director Quality-Steriles - Norwich Pharma Services : Job Details

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The Director of Quality - Steriles ensures the quality and compliance of sterile/combination products and medical devices. This role involves developing strategic direction, overseeing product operations within the Alvogen portfolio, and leading a team that interacts with external partners and CMOs. The Director manages complex sterile products throughout their lifecycle, supports adherence to Alvogen's Quality Management System, and ensures compliance with international standards such as QSRs, ISO 13485, and MDRs. Effective communication and multitasking in a fast-paced environment are essential.

The Director reports to the Sr. Director of Third-Party Quality, is based in Morristown, NJ, and oversees a team managing third-party suppliers for injectable/combination products.

• Provide leadership and supervision to the Quality team working with Contract Manufacturers.
• Ensure manufacturing, testing, and packaging compliance with cGMPs and regulatory requirements.
• Manage batch release processes and review all vendor batch documentation.
• Maintain regulatory compliance, quality agreements, and support GMP audits.
• Implement and ensure adherence to the Alvogen QMS and regulatory standards.
• Support interdepartmental collaboration, including supply chain and R&D.
• Act as the main Quality contact during due diligence activities for new acquisitions.

• BS in Pharmacy, Chemistry, Microbiology, or Biology with at least 15 years of industry experience, including 10 years in ISO 13485 certified organizations and 5 years in managerial roles.
• Extensive experience with injectable/combination products.
• Expert knowledge of cGMPs, FDA, USP, ISO, ICH guidelines, and EudraLex.
• Strong leadership, communication, and decision-making skills.

• Sitting at a computer for extended periods.
• Regular talking, listening, and meetings.
• Approximately 25-30% travel to external sites.

Authority to approve batch dispositions, standards, specifications, and release of products.

Note: This job posting is active and not expired.