Supplier Change Control - I

The Supplier Change Control Specialist I supports the Supplier Development & Performance Management (SD&PM) Change Portal Team, which centrally receives and tracks all supplier change notifications for external direct material suppliers. This role involves performing impact assessments, maintaining change control records, and supporting communication across global manufacturing and supply chain networks. The successful candidate will demonstrate strong organizational skills, technical expertise, and the ability to collaborate effectively within a matrixed organization to ensure supplier changes are properly evaluated and managed in compliance with cGMP and company standards.

Key Responsibilities

• Receive and review supplier change notifications for external direct material suppliers.
• Perform impact assessments to determine change level, affected manufacturing sites, and impacted products.
• Create and maintain change control records in the global electronic business system for tracking and communication.
• Support global External Supplier Change Control processes to ensure timely evaluation and approval of supplier changes.
• Verify and update supply chain data to ensure accuracy and completeness.
• Collaborate with cross-functional teams across Quality, Procurement, and Manufacturing Operations.
• Facilitate supplier communications and business negotiations in a professional and compliant manner.
• Contribute to continuous improvement initiatives related to supplier quality management systems.
• Ensure compliance with applicable cGMP, Quality, and regulatory requirements.

Skills & Qualifications
Required:

Education:

Bachelor’s degree in a Scientific, Engineering, or related field.

Experience:

• Minimum of 5 years in Technical, Quality, Procurement, Manufacturing Operations, or related business functions involving products or processes.
• Demonstrated Quality, Technical, and/or Manufacturing experience in pharmaceutical, medical device, and/or vaccine manufacturing or packaging.
• Strong understanding of Supplier Quality Management Systems, cGMPs, technical writing, and data management/analysis.
• Proven ability to work effectively in a matrix organization and collaborate across departments.
• Excellent interpersonal, inclusion, and communication skills; ability to build and maintain supplier relationships.
• Strong decision-making, prioritization, and problem-solving skills.
• Self-starter with the ability to work independently at all organizational levels.

Preferred:

• Experience with external supplier change control.
• Proficiency with Microsoft Excel and data analysis tools.
• Demonstrated ability to lead or participate in cross-functional team projects.
• Six Sigma Green Belt certification preferred.

Education:

Bachelor’s degree in a Scientific, Engineering, or related field required.