Quality Manager

Job description

• Oversee the overall management of all Qualityfunctions (Quality Assurance and Quality Control) and activities, ensuringcompliance with regulatory and company requirements.

• Manageand analyze Quality budgets and CAPEX planning, ensuring cost efficiency andcompliance, in coordination with Regulatory to align on budget plans and any changes.

• Liaise with Regulatory and Operations to ensure products are consistently manufacturedaccording 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 withregulatory requirements. Review and maintain QMS documentation required forregulatory file submissions (e.g., active substance Drug Master File (DMF), )or Certificate of Suitability to European Pharmacopeia (CEP) applications) tomeet ICH Common Technical Dossier requirements.

• Ensuretimely 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 GMPprocess 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.) ensuringregulatory and standards requirements are met.

• Collaborate with Regulatory in audit and inspection management, ensuring readiness, complianceto ISO, FSSC and GMP, and completeregulatory documentation, including supplier qualification, evaluation, andapproval processes.

• Support Regulatory in fulfilling Management Representative responsibilities forinternational standards certifications (ISO, FSSC, Halal) and take over ordelegated as acting Management Representative when required to ensurecontinuity.

• Lead recruitment,onboarding, training, mentoring and performance evaluation of Quality staff.

• Performother duties and responsibilities as assigned by the General Manager from timeto time.