Job Description

Job title: Quality System Lead

• Location: Singapore
• % Remote working and % of travel expected: To follow current arrangement for EVF Tuas: 40% remote (subject to change), possibility of 1 travel between 2023 to 2024.
• Job type: Permanent, Full time

Mission

Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur 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 EVF to reach its ambition. On top of it, VIA is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: \xe2\x80\x9cVIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+\xe2\x80\x9d.

In this context, we are looking for one Quality Management System (QMS) Lead for our new site based in Singapore.

Key Accountabilities

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

• The QMS Lead will be responsible to develop, implement provide strategic quality advices for the Quality Management System Processes to ensure the EVF QMS program meets Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.
• The incumbent will develop QMS infrastructures and execute QMS implementation strategies that are effective and fit for purpose to support the EVF SG GMP operations.
• Lead a team to manage the EVF QMS related activities and EVF project initiatives to support operational readiness and inspection readiness to ensure overall success and timeliness across the entire EVF project lifecycle and during routine operations.
• Responsible and owns the overall site Quality Management System, programs and procedures. Provides strategic direction, guidance and advice pertaining to Quality Systems, Quality Standards and Global Operating Procedures.
• Responsible for the overall EVF SG QMS is fully compliant to the applicable regulations, quality standards and procedural requirements. Establishment of robust QMS processes include but not limited to the following:

• Document Management System
• Deviations/CAPA/Change Controls
• Complaints & Recalls
• Disposition
• Audits and Inspection
• Responsible to monitor the overall health and performance of the entire EVF SG QMS Program to ensure system\xe2\x80\x99s robustness, and identify improvement opportunities.
• Lead and support QMS related trainings and coaching for the Quality organization.
• Lead and develop strategies/playbooks for QMS related topics to ensure successful regulatory inspections and site audits.
• A key EVF SG QMS representative and key member in the Quality Leadership Team to partner and collaborate closely with cross functional teams to achieve the EVF SG site operational goals/objectives.
• Contribute to reach the EVF quality manufacturing 4.0 ambition through a Quality plan.

Education and experience

• Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s Degree in Sciences, engineering or other related technical field.
• Minimum of 10 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).
• Minimum of 2-3 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 knowledge of the quality management systems and associated technologies.
• 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 validation strategy.
• Strong leadership skills and demonstrated solid success to lead QMS processes implementations.
• 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.
• Prior audit/inspection experiences to lead, strategize and drive inspection readiness activities to achieve impactful and successful outcomes during GMP inspections &/or Pre-Approval Inspections
• 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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Sanofi