Process Lead - QMS

Job Role: The position is responsible 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.

Duties & Responsibilities:

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 analysed, 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.

Training and Team Leadership

• Lead, coach, and develop the QA Compliance team, ensuring adequate training and competency development.
• Conduct and facilitate GMP and compliance-related training sessions for staff across departments.
• Foster a quality culture that emphasizes compliance, accountability, and continuous improvement.

Continuous Improvement and Risk Management

• Lead or participate in quality improvement and risk management projects.
• Identify compliance gaps and propose systematic solutions.
• Ensure proper implementation of data integrity principles (ALCOA+) across all quality systems.

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.
• Proficiency in MS Office and electronic QMS platforms.