Senior Quality Product Lifecycle Management Supervisor

We are seeking an experienced and detail-oriented Senior Supervisor to lead the daily operations of the Validation and Product Lifecycle team. In this critical role, you will oversee the validation lifecycle for equipment and processes, ensuring full compliance with cGMP, FDA/EMA regulations, and internal quality standards. The ideal candidate will act as the technical bridge between the Manager and the operational staff, providing mentorship to junior engineers while ensuring projects are delivered on time and within scope.

• Supervise, mentor, and develop a team of validation specialists and engineers.
• Assign daily tasks, monitor workload distribution, and ensure adherence to project timelines.
• Conduct performance reviews, identify training needs, and foster a culture of quality and continuous improvement.
• Act as the primary point of contact in the absence of the Department Manager.
• Ensure the Site Validation Master Plan (VMP) is maintained and executed effectively.
• Coordinate validation scheduling with Production, Engineering, and Quality Control departments to minimize downtime.
• Support the Product Lifecycle Management (PLM) strategy by monitoring Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) during commercial manufacturing (Stage 3 - Continued Process Verification).
• Lead investigations into deviations, non-conformances, and CAPAs related to validation and process performance.
• Assist in Change Management processes to assess the impact of proposed changes on the validated state of systems and processes.
• Ensure all validation activities comply with current Good Manufacturing Practices (cGMP), ICH guidelines, and relevant regulatory requirements (FDA, EMA, WHO).
• Serve as a Subject Matter Expert (SME) during internal and external regulatory audits (e.g., FDA inspections).
• Review and approve Standard Operating Procedures (SOPs) related to the validation department.

• Bachelor's degree in pharmacy, Chemical Engineering, Chemistry, Biology, or a related Life Sciences field.
• A master's degree is a plus.
• Minimum of 7-10 years of experience in the pharmaceutical industry, specifically within Validation, Quality Assurance, or Technical Services (Solid dosage forms , Sterile.
• Minimum of 2-3 years of experience in a supervisory or team lead role.
• Extensive hands-on experience with equipment qualification and process validation.
• Proven experience with cleaning validation strategies and risk assessment tools (FMEA, PHA).
• Proven experience in Oncology or Ophthalmology is a plus.
• Strong knowledge of global regulatory guidelines (FDA 21 CFR Part 210/211, Part 11, EU Annex 15, ICH Q8/Q9/Q10).
• Proficiency in statistical analysis tools (e.g., Minitab, JMP) for process capability assessment.
• Excellent technical writing skills for Policies , protocols, reports, and investigations.
• Strong leadership capabilities with the ability to motivate and guide a team.
• Excellent problem-solving skills and the ability to work under pressure.
• Strong communication and interpersonal skills to collaborate effectively across cross-functional departments.