Associate Director Quality Assurance

Job Description

• 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.

• 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.

• Bachelors 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.

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Preferred Skills:

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