Senior Quality Specialist

Senior Quality Specialist

The Senior Quality Specialist will be part of the Quality Assurance Department and will support Supplier Management activities at the Ridgefield site. This role is responsible for managing supplier-related quality processes, including Third-Party Change Notifications (TPCN), supplier corrective actions, and supplier qualification activities, while ensuring compliance with applicable GMP and regulatory requirements.

Roles and Responsibilities

• Manage the site's Third-Party Change Notification (TPCN) process, including logging, triaging, assignment, and determination of change criticality.
• Track TPCN activities to completion and prepare presentations for monthly review meetings.
• Review and approve third-party investigation reports related to supplier complaints and Supplier Corrective Action Reports (SCARs).
• Maintain and support the Supplier Qualification Program for both new and existing suppliers/vendors.
• Build and maintain strong professional relationships with suppliers to ensure adherence to quality standards and drive continuous improvement.
• Support updates to Standard Operating Procedures (SOPs) and act as backup for other Quality Supplier Management activities as needed.
• Perform quality trending, metrics generation, and reporting to ensure compliance and demonstrate effective control of quality systems.
• Collaborate with Manufacturing Operations, QA Management, Procurement, suppliers, and service providers to resolve compliance-related issues and proactively identify GMP risk areas.
• Author, review, and approve GMP documentation and support training activities related to supplier management.
• Assist in authoring, revising, and maintaining Quality Technical Agreements (QTAs) with vendors and service providers, working closely with Procurement and Legal teams.
• Support and/or lead quality projects and initiatives, leveraging prior experience in project management and continuous improvement.

Education and Experience

• Bachelor's degree in a science-related discipline.
• Minimum of 2 years of pharmaceutical industry experience.
• Strong experience in Supplier Management and supplier quality systems.
• Solid understanding of FDA regulations (21 CFR Parts 11, 210, 211, and 820) and ISO standards (ISO 13485, ISO 9001).
• Strong knowledge of quality and compliance within a regulated GxP/QMS environment.
• Experience handling ASL, QTAs, and working with QMS systems (Athena preferred).
• Excellent written, verbal communication, and organizational skills.
• Ability to multitask, adapt to change, and work effectively both independently and within a team.
• Strong problem-solving skills with the ability to research and apply past experience to drive successful outcomes.