Associate Director Quality Assurance

Key Responsibilities

As part of the global Quality Assurance organization, the Associate Director SQM will be responsible for:

• Supplier Quality Oversight: Managing the Approved Supplier List (ASL), ensuring suppliers meet GMP and regulatory requirements.
• Supplier Change Management: Acting as SME for supplier change notifications, evaluating impact, and ensuring proper approvals.
• SCAR & CAPA Management: Leading supplier corrective and preventive actions, ensuring timely closure and effectiveness verification.
• Audits & Inspections: Planning, leading, and supporting supplier audits, regulatory inspections, and follow-up actions.
• SQMS IT Systems: Overseeing Supplier Quality Management Systems (SQMS), ensuring validated status, compliance, and effective use.
• Global Stakeholder Management: Collaborating with stakeholders across global manufacturing sites, suppliers, and regulatory bodies to align quality expectations and ensure compliance.
• Risk Management: Implementing risk-based approaches for supplier qualification, monitoring, and escalation of compliance risks.
• People Management: Leading, coaching, and developing a team of Supplier Quality professionals to ensure operational excellence.
• Continuous Improvement: Driving innovation, efficiency, and GMP awareness in supplier quality processes.

Key Responsibilities

• Ensure suppliers are qualified, monitored, and maintained in compliance with GMP and global regulatory expectations.
• Lead supplier audits and manage audit findings, ensuring corrective actions are implemented effectively.
• Serve as SME for supplier change management, ensuring changes are assessed for impact on product quality and compliance.
• Manage SCARs and CAPAs with suppliers, ensuring timely resolution and effectiveness checks.
• Oversee SQMS IT systems, ensuring compliance with validation, change control, and data integrity requirements.
• Maintain and update the Approved Supplier List (ASL) in alignment with business and regulatory needs.
• Provide leadership, coaching, and performance management for Supplier Quality team members.
• Collaborate with global manufacturing sites to ensure consistent supplier quality practices across regions.
• Represent Supplier Quality in cross-functional and global meetings, driving resolution of supplier-related compliance issues.
• Support regulatory inspections and audits related to supplier quality management worldwide.
• Promote a culture of continuous improvement and GMP compliance across supplier quality processes.

Qualification & Requirements

Qualifications

• Bachelor’s degree in Science, Engineering, Information Technology, or Business (Advanced Degree preferred).
• Minimum 12 years of experience in regulated pharmaceutical manufacturing or supplier quality management, with at least 5 years in a leadership role.
• Strong understanding of FDA, EU, ICH, and other global regulatory requirements, with emphasis on supplier quality, GMP, and data integrity.
• Hands-on experience with supplier quality systems, supplier audits, and supplier change management across multiple global sites.
• Demonstrated expertise in SCAR, CAPA, and risk management processes.
• Familiarity with SQMS IT systems and computerized system validation.
• Excellent leadership, communication, and stakeholder management skills, with proven ability to manage global stakeholders.
• Professional certifications (Six Sigma, PMP, Quality Auditor) preferred.
• Multi-lingual capabilities and experience in leading regulatory inspection discussions are advantageous.

Required Skills

• Adaptability, Change Management
• Cross-Cultural Awareness
• Cross-Functional Teamwork
• ‘GMP Training
• Good Distribution Practice (GDP)
• Inspection Readiness
• Manufacturing Quality Control
• Quality Auditing
• Quality Management Standards
• Quality Metrics
• Quality Systems Compliance
• Regulatory Compliance
• Risk Management

Benefits

No information available.