Senior Quality Specialist

Job Title:
Senior Quality Specialist

Location:

Ridgefield, NJ
Duration: 12 Months

Job Description:
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.

Key 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.

Requirements:

• 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.