Senior Quality Compliance Specialist

Job Title

Senior Quality Compliance Specialist (Open)

Summary

The Senior Quality Compliance Specialist leads key elements of the Supplier Quality Management program to ensure suppliers, contract manufacturers, and service partners consistently meet regulatory, quality, and contractual requirements. This role oversees supplier qualification and performance monitoring, maintains and improves Supplier Quality processes and SOPs, and drives risk based decision making through robust metrics, scorecards, and analytics. The specialist prepares and presents supplier related insights to senior leadership, manages annual supplier performance reviews, and partners closely with cross functional teams to ensure effective Quality Agreement development and maintenance.

Essential Functions

• Lead the implementation and ongoing management of the Supplier Quality Management program for all suppliers, including contract manufacturers, service providers, and consultants.
• Maintain the Approved Supplier List (ASL), facilitate Supplier Selection Team meetings, conduct supplier evaluations, and create, review, and maintain Quality Agreements.
• Develop, maintain, and improve Supplier Quality SOPs to ensure alignment with regulatory expectations and internal standards.
• Provide comprehensive oversight of supplier performance through the creation and management of quality scorecards, metrics, dashboards, and analytics to proactively identify risks and drive continuous improvement.
• Prepare and deliver Management Review materials that clearly communicate supplier risk, performance trends, key issues, and improvement priorities to senior leadership.
• Manage the Annual Supplier Performance process and oversee supplier governance mechanisms, including the Approved Supplier List (ASL), Vendor Selection Team (VST), and strategic supplier oversight initiatives.
• Partner with cross functional stakeholders-including site and functional quality management teams-to ensure that the Quality Agreement (QAG) process meets all applicable quality, regulatory, and contractual requirements.

Minimum Requirements

• Bachelor's Degree.
• Minimum of 6 to 8 years' experience in the FDA regulated industry.
• Demonstrated knowledge, including practical application, of QSR/GMP (21 CFR Part 210, 211, 820) regulations and ISO (ISO 13485)/EU standards.
• Excellent organizational, managerial and people skills.
• Ability to evaluate data and quality issues and organize and present complex data in a simple and concise manner.
• Ability to interpret regulatory requirements and implement appropriately.

Organizational Relationships / Scope

Reports to: Senior Manager, Quality and DRP.
Direct Reports: None.

Working Conditions

Normal office conditions. Hybrid model (3 days in the office).

Equal Employment Opportunity

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions, practices and observances; national origin; pregnancy; childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.