Supplier Quality Management (SQM) Supervisor
About The Position
The Supplier Quality Management (SQM) Supervisor plays a critical role in building and maintaining Capricorâs worldâclass supplier quality program. This position oversees supplier qualifications, audit activities, supplier performance monitoring, and compliance with global GMP requirements across the supply chain. The role requires strong collaboration with Procurement, Manufacturing, QC, R&D, and other functional partners to ensure that externally supplied materials and services consistently meet Capricorâs quality standards. This position is ideal for detailâoriented quality professionals with deep experience in GMP/GLP environments and a passion for continuous improvement.
Requirements
- Bachelorâs degree in Life Sciences or a related field.
- 5â7 years of experience in supplier quality management, QA, or related functions within pharma, biotech, or medical devices.
- Minimum 2 years in a supervisory or leadership capacity.
- Strong expertise in GMP compliance, supplier auditing, and qualification processes.
- Working knowledge of FDA 21 CFR Part 211, EU GMP (including Annex 1), ICH guidelines, and ISO 13485.
- Deep understanding of supply chain processes and riskâbased quality assessments.
- Excellent analytical, problemâsolving, and communication skills.
- Highly organized with strong attention to detail.
- Proficiency with MS Word, Excel, Visio, Adobe Suite, and eQMS platforms.
- Ability to work independently and adapt within a fastâpaced environment.
Nice To Haves
- Experience overseeing suppliers supporting biologics, advanced therapies, or aseptic manufacturing.
- Handsâon experience with CAPA management, audit programs, and supplier remediation.
- Familiarity with quality systems and ERP tools (e.g., Veeva, Qt9, NetSuite, SAP).
- Experience supporting regulatory inspections focused on supplier controls.
- Strong understanding of quality agreements, material specifications, and technical documentation.
Responsibilities
- Lead the implementation of Capricorâs Culture of Quality across all supplierârelated operations.
- Ensure adherence to FDA, EMA, and global GMP requirements across supplier quality processes.
- Develop, maintain, and continuously improve supplier quality procedures, documentation, and systems.
- Serve as the primary quality contact for supplierârelated regulatory inspections.
- Conduct supplier qualification assessments, audits, and ongoing evaluations.
- Manage and maintain supplier documentation, including quality agreements, specifications, and audit reports.
- Monitor supplier performance metrics, trend results, and identify risks.
- Address supplierârelated nonâconformances and lead or support CAPAs to ensure effective root cause analysis.
- Drive continuous improvement initiatives strengthening supplier oversight and overall supply chain robustness.
- Support and contribute to supplierârelated quality risk assessments.
- Perform or support investigations tied to supplier deviations, material issues, and process failures.
- Conduct root cause analysis and implement appropriate corrective and preventive actions.
- Partner with procurement, manufacturing, and R&D to ensure material quality and compliance throughout the product lifecycle.
- Provide guidance on supplier requirements for new materials, process changes, and technical evaluations.
- Deliver training related to supplier quality practices and GMP compliance.
- Ensure supplier readiness for audits and regulatory inspections.
- Support quality systems initiatives, documentation improvements, and operational excellence projects.
- Perform additional duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
