Senior Manager, Client Quality, Technical and Validation

PCI Pharma Services seeks a Senior Manager to provide strategic leadership over Client Quality Account Management and Validation functions at the Tredegar site. The role involves leading cross-functional teams, ensuring GMP compliance, managing client relationships, and driving continuous improvement across quality operations.

Responsibilities

• Lead and develop Quality Account Manager and Validation teams with clear objectives and performance monitoring
• Oversee client quality requirements, NPI, licensing, regulatory submissions, and Quality Agreements
• Direct validation activities for processes, equipment, utilities, cleaning, and computer systems
• Review and approve client documentation, validation protocols, and change control documentation
• Ensure GMP compliance across the site through departmental visits and guidance; act as escalation point for complex matters

Requirements

• Extensive pharmaceutical quality function experience
• Demonstrated people management and team leadership ability
• Strong written and verbal communication skills
• Statistical and advanced mathematical proficiency
• Advanced computer skills and GMP/regulatory knowledge
• Ability to travel and support regulatory inspections
• High-level report writing and presentation capability