Senior Manager, Validation (Modulus Singapore)

Job title: Senior Manager, Validation (Modulus Singapore)

Location: Singapore

Hiring Manager: Head of Manufacturing

About the job:

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products. One of these two facilities is implemented in Singapore in a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.

The Manufacturing team in Sanofi Modulus, Singapore is seeking to expand the team and has an open position as Senior Manager, Validation. This role is responsible for implementing and maintaining qualification and validation strategies, plans, protocols, and reports, in collaboration with internal and external stakeholders.

Main responsibilities:

The role will report to the Head of Manufacturing. In this role, the Senior Manager, Validation will play a key role in ensuring that all equipment, facilities, cleaning and disinfection are properly qualified, validated and maintained in their Q&V status.

The Senior Manager (Validation) is accountable to:

• Implement andmaintain qualification and validation strategies, plans, protocols, and reports,in collaboration with internal and external stakeholders
  
• Maintain and update thevalidation master planand procedures, and ensure alignment with the company's quality management system
  
• Ensure thecompliance of qualification and validationwith applicable regulatory requirements and company quality standards.
  
• Ensure the proper documentation, review, and approval ofqualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports
  
• Ensure that allequipment and facilities are properly qualifiedand validated
  
• Ensure that equipment cleaning is properly validated
  
• Maintain the validation of sterilization cycles (e.g. autoclave, VHP, SIP) and surface disinfection (chemical and UV)
  
• Oversee theexecution of qualification and validation studies
  
• Establish metrics andmonitor data for the qualification and validation activities, to identify trends and issues
  
• Conduct periodic reviews of validated systems and perform re-validation as necessary.
  
• Establish and monitorkey performance indicators(KPIs) and metrics for the qualification and validation, and report on the qualification and validationperformance and effectiveness.
  
• Identify and drivecontinuous improvement initiativesand projects to enhance the qualification and validation efficiency and effectiveness fostering a culture of continuous improvement
  
• Evaluate and recommendnew technologies, tools, and methodsto enhance qualification and validation processes and outcomes
  
• Lead andmanage the qualification and validation team, including hiring, training, coaching, professional development and performance evaluation.
  

About You

Qualifications / Requirement

• Bachelor's Degree in a related Engineering or Science discipline.
  
• >10 years of relevant working experience in the cGMP biopharmaceutical facility.
  
• Previous hands-on qualification/validation experience with equipment, facilities, cleaning and disinfection would be an advantage.
  
• Familiarity and prior working experience with Single Use Systems would be preferred.
  
• Experience working with computer systems, e.g. DeltaV, MES, would be preferred.
  
• Experience in change management, stakeholder management, process innovation and optimization.