Process Lead - QMS

Job Description:

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.

• 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.

• 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.
• Support departments in documentation compliance and timely updates of controlled procedures.

• 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.

• 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.

• 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.
• Proficiency in MS Office and electronic QMS platforms.