Head of Quality Excellence

Job Title: Head of Quality Assurance

Overview:

This is a critical role that will be responsible for the overall quality management system within our organization.

The successful candidate will lead and manage the development, implementation, and maintenance of quality systems to ensure compliance with regulatory requirements and industry standards.

Key Responsibilities:

• Develop, implement, maintain, and improve quality audit, GMP quality systems, and behavioral GMP aspects.
• Coordinate and perform all vendor qualification activities for raw materials, packing materials, quality control external testing laboratories, and any other outsourced activities, internal audits, and compliance audits.
• Responsible for coordination and finalization for qualified person audits and regulatory inspections.
• Responsible for CAPA close-out for all audits and inspections.
• Develop, maintain, and improve a GMP-compliant document control system.
• Establish a robust quality management system (QMS) to manage and implement change management, deviation management, incidents, complaint handling, and CAPA management.
• Responsible for all GMP trainings and quality training programs.
• Oversee investigations of all non-conformances (deviations, complaints, etc.).
• Responsible for handling product recalls.
• Create and maintain a system to implement the requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System).
• Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the company.
• Develop batch release and reject systems to ensure quality products are released to the market.
• Work across all disciplines (e.g., manufacturing, warehouse & QC, etc.) to ensure that the company maintains a state of readiness for inspection by regulatory agencies.
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes.
• Lead, manage, and ensure proper training to any relevant change management programs throughout the company.
• Provide quality guidance to product development projects and programs.
• Responsible for data integrity internal audits, training, and review and reporting to the management.
• Ensure all validation activities (process/cleaning/method/equipment, etc.) are carried out according to approved protocols and requirements.
• Well-versed with requirements of injectable products, facility requirements, and media fill requirements.
• Responsible for technology transfer documents, compile necessary records, and smooth transmission to meet and comply with regulatory requirements.
• Maintaining and improving departmental operational performance to meet the requirements of regulatory authorities, company standard operating procedures (SOPs), and external and internal customers, with respect to quality, service, lead time, and cost.
• Ensure the development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being fit for purpose operationally and commercially.
• Ensure that all activities are performed in accordance with GMP, company SOPs, and health and safety policies.
• Ensure that there is a self-inspection program in place to meet the requirements of EU GMP/PICS/TG/MHRA, etc.
• To review, approve, and issue batch manufacturing records/batch packaging records.
• Responsible for OOS and OOT.
• Organize review meetings and document their actions and corrective measures implemented for cGMP requirements.
• Monitor IPQA activities, review, and report.
• Responsible and nominated by management as cGMP administrator.
• Responsible for preparation, review, finalization, and timely submission of documents if any to external customers and agencies as per regulatory requirements.
• Responsible for adherence to validation master plan and adherence to the validation schedule.
• Responsible for control sample management (final retention samples) along with QC.
• Responsible for stability management along with QC team.
• Responsible for quality review meetings and management review meetings.
• Responsible for documentation cell and lifetime documents archival program.
• Responsible for artwork approval and shade card maintenance.
• Responsible for label management and risk management.
• Responsible for shredding and maintenance.
• Responsible for reviewing all layouts along with engineering team.
• Responsible for reviewing pest control management, fire extinguisher annual documents along with EHS, HR, and engineering team.
• Responsible for reviewing and finalizing water system validation documents along with engineering department.
• Responsible for conducting transport validation, review, and finalize protocol/reports.
• Responsible for national and international manufacturing licensing activities along with regulatory affairs team for the site and archival.
• Responsible for quality agreements and vendor agreements and adherence.
• Responsible for all dispatches of finished products as per country-specific approvals.