Procurement Operations Specialist

The Procurement Operations Specialist is a third-party contract role that oversees the end-to-end lifecycle of R&D and manufacturing suppliers. This role balances strategic procurement (supplier management, onboarding, performance) with strict quality compliance. The candidate will act as the primary owner of the Veeva Quality Management System (QMS) workflow for external vendors, driving audits, change controls, deviations, Supplier Corrective Action Requests (SCARs), and Corrective and Preventive Actions (CAPAs). A Procurement Operations Specialist ensures that an organization's purchasing activities, vendor materials, and supplier networks meet internal quality standards and external regulatory requirements.

Core Responsibilities

1. Supplier Management & Procurement

• Serve as the primary operational and quality liaison between pharmaceutical manufacturing/R&D teams and external suppliers.
• Manage supplier performance metrics, conduct regular business reviews, and mitigate supply chain quality risks.
• Oversee the qualification and onboarding process for new raw material, API, and clinical trial suppliers.
• Participate in Impact Assessments, Supplier assessment, Supplier and Material Changes Require Formal Evaluation and Supply chain traceability form and site quality overview.

2. QMS & Veeva Process Ownership

• Direct and manage the full lifecycle of supplier workflows within the Veeva QMS platform along with internal and external stakeholder management.
• Ensure all supplier-related data, documentation, and history are accurately maintained and audit-ready in Veeva.

3. Audits & Compliance

• Partner with the QA, QC, MSAT, SCM, Production, Regulatory and other teams to coordinate, execute, and follow up on supplier quality audits.
• Ensure suppliers adhere to cGMP, FDA, EMA, and other relevant global regulatory frameworks.

4. Change Notifications, SCARs, and CAPAs

• Evaluate and process Supplier Change Notifications (SCNs) to assess their impact on R&D or manufacturing processes.
• Issue and track SCARs when supplier materials or services fail to meet established specifications.
• Lead root-cause analysis investigations with suppliers to develop, implement, and close out effective CAPAs.

Qualifications and Skills

• Education: Bachelor's degree in supply chain, Quality Management, Life Sciences, Engineering, or a related discipline.
• Experience: 3 to 5 years of experience in quality assurance, vendor management, or procurement compliance within a regulated industry.
• Regulatory Knowledge: Familiarity with standards such as ISO 9001, AS9100, cGMP, or FDA regulations depending on the sector.
• Certifications: Preferred credentials include ASQ Certified Quality Auditor (CQA) or Lean Six Sigma.