Quality Assurance Senior Supervisor

We are seeking Quality Assurance Senior Supervisor to lead and oversee Quality projects ensuring full compliance with EU GMP requirements and regulatory expectations. The role is responsible for driving site readiness for EU approval, implementing quality excellence programs across QA and QC functions, and leading Lean Laboratory initiatives to enhance efficiency, compliance, and performance.

• Lead site preparation for EU regulatory inspections and approvals.
• Perform comprehensive gap assessments against EU GMP, Annex 1, and relevant guidelines.
• Develop and execute remediation plans to close compliance gaps.
• Ensure QA systems, documentation, and processes meet EU regulatory expectations.
• Support mock audits, corporate audits, and regulatory inspections.
• Coordinate responses to inspection observations and ensure timely closure of CAPAs.
• Maintain inspection readiness at all times.

• Lead the implementation of a Quality Improvement Plan projects in quality department and monitor the implantation across the site.
• Establish performance dashboards and quality performance indicators.
• Promote a quality culture aligned with global regulatory expectations.
• Drive human error reduction programs.
• Facilitate cross-functional quality improvement initiatives.

• Lead Lean Laboratory projects to improve efficiency, reduce waste, and optimize workflows.
• Implement 5S, visual management, and standard work practices in QC labs.
• Reduce laboratory turnaround times (TAT).
• Optimize sampling and testing workflows.
• Facilitate root cause problem-solving sessions.

• Ensure effective GMP and EU regulatory training programs.
• Mentor QA officers and supervisors.
• Promote accountability and quality ownership culture.
• Support competency assessments and training effectiveness evaluation.

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.
• EU GMP knowledge is mandatory.
• Certification in Quality Management / Lean / Six Sigma is preferred.
• Minimum 10–15 years in pharmaceutical manufacturing.
• Minimum 6–8 years in QA leadership role.
• Strong knowledge of EU GMP & Annexes (especially Annex 1 if sterile site).
• Experience with regulatory inspections (EU/MHRA/EMA experience preferred).
• Deep understanding and expertise of QMS systems
• Strong knowledge of Data Integrity requirements.
• Experience in Lean Lab or operational excellence initiatives.
• Knowledge of validation and qualification lifecycle.
• Strong leadership and team management skills.
• High attention to details.
• Strategic thinking and problem-solving capability.
• Strong communication and audit-facing confidence.