Team Leader -Change Management & Risk Management

• Lead and manage daily QA compliance operations, ensuring adherence to company and regulatory requirements.
• Oversee the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Supervise review and closure of deviations, CAPAs, change controls, and risk assessments.
• Ensure quality system data is analyzed, trended, and reported through compliance KPIs and management reviews.

• Plan, coordinate, and lead internal audits and self-inspections according to the annual audit schedule.
• Prepare the organization for regulatory inspections and customer audits; coordinate responses and follow-up on findings.
• Review and approve audit reports and ensure timely and effective implementation of corrective and preventive actions (CAPAs).

• Supervise the control, review, and approval of SOPs, quality manuals, and other controlled documents.
• Ensure compliance with Good Documentation Practices (GDP) and manage document lifecycle from issuance to archival.

• Lead the end-to-end Change Control lifecycle (initiation, impact assessment, approval, implementation, closure).
• Ensure all changes are evaluated for GMP, regulatory, validation, and supply chain impact.
• Chair or coordinate Change Control Committee (CCC) / Panel meetings.
• Ensure timely closure of changes within defined KPIs (e.g., extension rate ≤ target).
• Oversee classification of changes (minor / major / critical) based on risk.
• Ensure alignment with regulatory submissions/variations where applicable.
• Monitor effectiveness checks and post-implementation review (PIR).

• Implement and maintain QRM framework in line with:
• ICH Q9 (Quality Risk Management)
• WHO Annex 9
• EU GMP Chapter 1
• Lead risk assessments (FMEA, HACCP, risk ranking, etc.) for:
• Change controls
• Deviations and CAPAs
• New product introduction (NPI)
• Supplier qualification
• Ensure risk-based decision making is embedded across QMS.
• Maintain risk registers and risk review mechanisms.
• Facilitate cross-functional risk workshops.

• Lead and coach the CC & QRM team.
• Ensure proper training and competency development.
• Promote a quality culture and risk-based mindset.
• Allocate workload and ensure performance against KPIs.

• Follow the company's Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
• Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
• Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiatives.

• Bachelor's or Master's Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related or equivalent field
• Minimum 5-10 years of experience in Quality Assurance / Compliance within the pharmaceutical or biotechnology industry, including at least 2-3 years in a supervisory or team leadership role.
• Comprehensive understanding of GMP, GDP, and ISO 9001 and ISO 14001 requirements
• Strong familiarity with regulatory guidelines (FDA, WHO, EU).
• Experience in audits, CAPA, risk management, and QMS systems.
• Excellent leadership and team management skills.
• Strong communication, coordination, and decision-making abilities.
• Analytical thinking and problem-solving skills.
• Proficiency in MS Office and electronic QMS platforms.

Julphar