Senior Manager, External Quality

Senior Manager, External Quality

Location : Lexington, MA

Education level : Master or PhD

Job category :

Global Quality Operations

Target start date : 3 / 3 / 2025

Work Location : On-Site

Shift :

Place in the Organization

The Senior Manager of External Quality is responsible for managing quality operations with external partners and CMO's / CTL's. The Senior Manager of External Quality is a Quality professional with extensive experience in GMP supplier audits, vendor management practices and leading external audit programs. The candidate is responsible to establish and implement a robust Supplier Management and Audit program. The candidate will ensure the current quality practices and standards at external suppliers, sites (CMO / CTL) are compliant with regulatory requirements and internal standards. This role requires strong cross functional collaboration.

Key result areas (major duties, accountabilities, and responsibilities)

• Oversees CMO management related to quality operations
• Drives, leads, and troubleshoots quality investigations at CMO / CTLs in conjunction with appropriate SMEs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
• Improve and maintain policies and SOPs to support the Supplier Audit management programs and integrate operations into the Quality Management System.
• Lead or oversee internal and externalaudits.
• Provide inspection readiness support for third-party audits and regulatory inspections.
• Support the supplier quality program through review and approval of vendor change notifications, part number requests, and raw material specifications, as necessary.
• Provide Quality oversight and direction to uniQures Computer System Validation (CSV) program by reviewing and approving program SOPs and CSV deliverables.
• Provide the organization with Data Integrity subject matter expertise to support product development at external parties and ensure regulatory filings are accurate and traceable to source data.
• Maintain Approved Suppler List and responsible for implementing and maintaining Quality Agreements with Suppliers.
• Responsible for developing and maintaining a high-performing External Quality organization to effectively execute organizational responsibilities.
• Provide metrics related to External Document Control, Training, and QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and external audits performance to Management.
• Collaborate with other Quality leaders to ensure compliance with all relevant Quality Management Systems and processes are maintained and in line with global regulations and in alignment with the company's strategy.

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