Oversee the overall management of all Quality functions (Quality Assurance and Quality Control) and activities, ensuring compliance with regulatory and company requirements.
Manage and analyze Quality budgets and CAPEX planning, ensuring cost efficiency and compliance, in coordination with Regulatory to align on budget plans and any change.
Liaise with Regulatory and Operations to ensure products are consistently manufactured according to quality standards, specifications, and regulatory requirements. Ensure compliance with GMP, ISO, FSSC, Halal, Kosher, and EHS policies and objectives.
Oversee certification maintenance (ISO, FSSC, GMP, Halal, Kosher) in alignment with regulatory requirements. Review and maintain QMS documentation required for regulatory file submissions (e.g., active substance Drug Master File (DMF), or Certificate of Suitability to European Pharmacopeia (CEP) applications) to meet ICH Common Technical Dossier requirements.
Ensure timely investigation and closure of non-conformances (deviations, OOS, complaints, recalls/returns) in collaboration with Regulatory to resolve quality/ food safety issues, while leading multidisciplinary teams to address GMP process failures ensuring compliance and business continuity.
Create/ review / revise and or approve Quality Management System documentations (e.g., SOP, WI, equipment validation/qualification protocol/report, CAPAs, Change Control, OOS, Deviations Complaints, batch records, etc.) ensuring regulatory and standards requirements are met.
Collaborate with Regulatory in audit and inspection management, ensuring readiness, compliance to ISO, FSSC and GMP, and complete regulatory documentation, including supplier qualification, evaluation, and approval processes.
Support Regulatory in fulfilling Management Representative responsibilities for international standards certifications (ISO, FSSC, Halal) and take over or delegated as acting Management Representative when required to ensure continuity.
Lead recruitment, onboarding, training, mentoring and performance evaluation of Quality staff.
Perform other duties and responsibilities as assigned by the General Manager from time to time.
Job Requirements
Deep working knowledge of GMP / GxP / FSSC / ISO systems / PICS / ICH
Strong understanding of risk-based thinking (HACCP, FMEA, QRM)
Proven capability in deviation management, root cause analysis, CAPA effectiveness, change management, supplier qualification and validation principle
Sound knowledge of change management and validation principles
Communicate clearly and assertively with external regulators, auditors, and customers
