Job Title: Manager Supplier Quality
Department: Global QMS
Education Qualification: MSc / MPharm (Pharmaceutical Sciences, Biotechnology, or related discipline)
Key Responsibilities -
Supplier Quality Management
- Lead qualification, approval, and periodic evaluation of suppliers for biologics raw materials and components.
- Conduct on-site and remote GMP and quality system audits.
- Monitor supplier performance through metrics, scorecards, and periodic business reviews.
- Ensure timely investigation and closure of Supplier Corrective and Preventive Actions (SCARs/CAPAs).
- Perform supplier risk assessments and maintain risk categorization and mitigation plans.
Material Quality & Compliance
- Oversee quality aspects of biologics raw materials, including media, buffers, chromatography resins, excipients, and single-use components.
- Support raw material qualification and lifecycle management.
- Collaborate with Manufacturing, Process Development, QC, and Supply Chain on material-related investigations and issues.
- Ensure compliance with internal specifications, pharmacopeial standards, and global regulatory expectations.
Quality Systems & Issue Management
- Lead supplier-related deviations, non-conformances, and root cause investigations.
- Drive structured problem-solving and implement sustainable preventive and corrective actions.
- Manage vendor change controls, including regulatory and operational impact assessment.
- Ensure effective cross-functional communication and alignment.
- Establish, maintain, and review Quality Agreements with critical suppliers and CMOs.
Regulatory & Inspection Management
- Provide support during USFDA, EMA, and other regulatory inspections.
- Represent Supplier Quality during internal, customer, and regulatory audits.
- Align supplier quality processes with global regulatory requirements and industry best practices.
Leadership & Team Management
- Lead and manage a Supplier Quality team of approximately 67 members.
- Provide coaching, development, and performance management.
- Foster a culture of compliance, quality excellence, and continuous improvement.
Experience Requirements -
- Minimum 15+ years of pharmaceutical/biologics quality experience.
- At least 5 years in supplier qualification, supplier audits, and supplier quality management.
- Minimum 2+ years of team management experience (67 members).
- Hands-on experience supporting USFDA and EMA inspections.
- Strong understanding of GMP, supplier audits, biologics manufacturing, and quality systems (ICH Q7/Q9/Q10).
