Head of Quality Assurance

• Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets

• To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing.

Key Responsibilities

• Quality Systems & Compliance
• Implement, maintain, and continuously improve Quality Systems in line with ICH Q7, EU GMP, 21 CFR Parts 11, 210, 211, Annex 11, and other applicable global regulations for APIs.
• Ensure site-wide compliance with internal quality policies, SOPs, and regulatory guidelines.
• Oversee preparation, revision, and effective implementation of quality-related SOPs, policies, and quality manuals.
• Vendor Qualification & Management
• Establish and maintain procedures for vendor approval, qualification, periodic evaluation, and rejection.
• Ensure technical and quality assessment of raw material, intermediate, and service providers in alignment with regulatory and company standards.
• Drive supplier quality improvement initiatives and manage critical vendor-related quality issues.
• Change Control, Deviations, Risk & Product Quality Review
• Review and approve major process changes and critical quality-impacting changes through the Change Control system.
• Review and approve Annual Product Quality Reviews (APQR/PQR) and ensure implementation of improvement actions.
• Review and approve critical deviations, investigations, and associated Corrective and Preventive Actions (CAPA).
• Lead Quality Risk Management activities and ensure implementation of risk mitigation strategies.
• Oversee preparation, review, and approval of Site Master File (SMF).
• Investigations, OOS/OOT, Rework & Repacking
• Ensure thorough, timely, and scientifically sound investigations of OOS (Out of Specification), OOT (Out of Trend), and other critical quality events.
• Approve and oversee activities related to repacking, relabeling, rework, and associated deviations, ensuring compliance and product integrity.
• Ensure effective root cause analysis and CAPA implementation for all critical quality issues.
• Market Complaints & CAPA
• Ensure robust investigation of market complaints, including coordination with cross-functional teams.
• Approve complaint investigation reports and ensure effective CAPA and follow-up to prevent recurrence.
• Monitor complaint trends and drive continuous improvement initiatives based on trend analysis.
• Regulatory Audits & Inspections
• Lead preparation for, coordination of, and responses to regulatory inspections and customer audits (USFDA, TGA, EU/WHO, ANVISA, and other authorities).
• Ensure timely closure of audit observations with effective, sustainable CAPA.
• Maintain a state of constant audit readiness across the site.
• People Leadership & Training
• Lead, mentor, and develop the Quality Assurance and related quality teams to build strong technical and compliance capabilities.
• Plan and implement training programs on GMP, data integrity, quality systems, and regulatory updates for all relevant personnel.
• Foster a culture of quality, transparency, and continuous improvement across the organization.

Qualifications

• M.Pharm / B.Pharm / M.Sc (Chemistry) or higher degree in a relevant scientific discipline.
• Minimum 20 years of experience in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with at least 58 years in a senior leadership role.
• Strong knowledge of ICH Q7, EU GMP, 21 CFR Parts 11, 210, 211, Annex 11 and other global GMP requirements applicable to APIs.
• Proven experience in handling multiple regulatory inspections (e.g., USFDA, TGA, EU, WHO, ANVISA, etc.).

Key Competencies

• Strong leadership, team management, and decision-making skills.
• Deep understanding of GMP, quality systems, and regulatory expectations for APIs.
• Excellent analytical, investigation, and problem-solving skills (RCA, risk assessment, CAPA).
• Strong communication, stakeholder management, and audit-facing skills.
• High integrity and strong focus on data integrity and compliance.