Supplier Quality Mgt Specialist II

Responsibilities

• Assist in and support audits to assess supplier and service provider compliance with applicable cGMPs, SOPs, and regulatory requirements (FDA, ICH, ISO).
• Draft, review, negotiate, and maintain Quality Technical Agreements (QTAs) with suppliers and service providers.
• Manage Supplier Change Notifications (SCNs), including performing impact assessments and coordinating actions with internal stakeholders.
• Lead and support deviation investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Supplier Corrective Action Requests (SCARs).
• Track, trend, and report supplier and service provider quality performance metrics (KPIs).
• Create, review, and maintain cGMP-related documentation, specifications, and quality records.
• Conduct quality risk assessments for new and existing suppliers, materials, and services.
• Assess adherence to current Good Manufacturing Practices (cGMP), company policies and procedures, and applicable regulatory guidelines (FDA, EMA, ICH).
• Collaborate cross-functionally with Regulatory Affairs, Quality Assurance, Quality Control, R&D, Manufacturing, and external partners, including supporting regulatory inspections.
• Participate as a team member on cross-functional initiatives and continuous improvement projects.
• As a member of the External Quality team, additional responsibilities related to Quality Audit Management may apply.
• May perform other duties as assigned.

• Bachelor's degree in Life or Physical Sciences, Engineering, or related field.
• Significant (5+ years) experience in pharma/biotech, SQM, supplier auditing, GMP environments, and managing regulated materials.

• Strong analytical, problem-solving, communication, negotiation, and project management skills.
• Ability to work in a fast-paced, team-oriented environment.
• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.
• Working knowledge of FDA 21 CFR Parts 210/211, ICH Q7, ISO standards (e.g., ISO 9001).
• Experience in Quality Management Systems (QMS), ERPs (e.g., Track Wise, Master Control), and RCA tools (5 Whys, Fishbone).

• ASQ CQE, ASQ CQA, Six Sigma certifications are a plus.

May travel occasionally to conduct audits relevant to functions of this position.

This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.

☐ Medical Surveillance Program Required