Senior Manager, Quality Operations

Job title: Senior Manager, Quality Operations

Location: Singapore

Hiring Manager: Head of Quality

Mission

Sanofi 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. Digital will be one of the key topics to help Modulus to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.

In this context, we are looking for Senior Manager, Quality Operations, for our site based in Singapore.

About the job:

Key Accountabilities

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The Senior Manager, Quality Operations, will be responsible to partner with GMP operations team to provide quality oversight and advice for Quality on-the-floor and operations support to ensure the Modulus Singapore GMP quality operations meets Sanofi global quality standard requirements and fulfil the applicable regulatory expectations. The position requires in-depth experience in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple quality systems (including exception management, change controls, deviations/CAPAs and document management system).

The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, quality control and technical units) to ensure quality, safety, reliability, efficiencies to support Modulus Singapore GMP manufacturing operations. 

• Responsible to shape, influence and provide quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor quality oversight, raw materials release, deviations, change controls and CAPAs) at Modulus Singapore manufacturing facility. 
• Accountable to ensure all quality related operational procedures, infrastructures are successfully implemented to support Modulus Singapore site operational and inspection readiness and success.   
• Coach and mentor cross functional team members with the goal to establish an engrained quality culture across the organization. 
• Key quality representative to resolve complex issues, and participate in root cause investigations, leveraging in root cause analysis tools and methodologies. 
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase. 
• Strategizing, reviewing and approving playbooks for direct manufacturing related topics to ensure the success of regulatory inspections and site audits. 
• Lead and participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).    

• Escalate significant quality issues to Quality management in a timely manner.
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• Contribute to reach the Sanofi Manufacturing 4.0 ambition through a Quality plan.

About You:

Education and experience

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field. 
• Minimum of 10-12 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).
• Minimum of 5 years of managerial experiences to lead a team effectively in a matrix environment.

Key technical competencies and soft skills:

• Manufacturing 4.0 mindset (such as Agile methodology)
• Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
• Solid manufacturing process technical knowledge.
• Broad and in-depth understanding of QA Operations (from an end-to-end perspectives).
• Strong interpersonal relationships in order to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
• Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy and execution.
• Familiarity with electronic batch record (MES) and lot disposition process using SAPsystem.
• Strong leadership skills and demonstrated solid success to lead QA Operations related activities.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.
• Experienced in facility start-ups will be advantageous
• Good understanding of risk-based decision framework
• Experience in working internationally and cross-functionally
• Familiar with Digital 4.0 concepts and potential applications in Quality