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.
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.
