To lead and oversee the Quality Assurance Compliance team in ensuring that all operations comply with cGMP, GDP, ISO, and regulatory requirements. The QA Compliance Process lead is responsible for supervising quality system activities, managing audits and inspections, and driving continuous improvement initiatives to maintain a high standard of quality compliance across the organization.
Quality System Oversight
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.
Audits and Inspections
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).
Documentation and Records Management
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.
Support departments in documentation compliance and timely updates of controlled procedures.
Change control management
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).
Continuous Improvement and Risk Management
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.
Team Leadership
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.
Environmental, Health and Safety Responsibilities
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.
Qualification/Functional Knowledge
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.
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mid
4/13/2026
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