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 Quality Engineering & Validation (QEV) Specialist for our new EVF 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 QEV Specialist will be responsible to partner with technical operations team to provide quality oversight during the entire commissioning, qualification and validation lifecycle to ensure the EVF Singapore Project meets Sanofi global quality standard requirements and fulfil the applicable regulatory expectations.

The incumbent shall be experienced in employing a risk-based and science-based approach to the specifications, design, and verification of GMP operational systems and equipment. Ensures the quality, safety and compliance in the manufacturing and supply of EVF Singapore manufactured products.

• Responsible to shape, influence and provide advice on the Quality Engineering and Validation strategic program/activities, alongside with solid understanding of Quality Risk Management principles and methodologies.
• Partners closely with the cross functional technical teams to define overall commissioning, qualification and validation related strategies and activities (e.g. VMP, CQ Plan, Cleaning Validation Plans etc.)
• Provides quality oversight across the validation program lifecycle (from development, qualification, and continued verification phases), using a science-based and risk-based approach.
• Lead and develop strategies/playbooks for QEV related topics to ensure successful regulatory inspections and site audits.
• Ensures that EVF Singapore CQV activities meet the internal Sanofi quality standard requirements and fulfil regulatory expectations.
• During the EVF Project phase, functions as a key Quality reviewer and approver of applicable CQV related documentations (e.g. plans, procedures, protocols, summary reports etc.) include but not limited to the following topics:
  • Facilities, Equipment and Utilities
  • Controlled Temperature Chambers
  • Cleaning, Sterilization, Autoclave Validation
  • Process Validation & Continued Process Verifications
  • Validation Maintenance Program
  • Transport Validation
• Independent technical contributor to partner with cross function technical teams (internal and external) to monitor the overall health and performance of Validation Program to ensure system robustness and identify opportunities to support continuous improvements.
• Lead and support Validation related trainings and coaching for the Quality organization.
• A key EVF SG Project Quality key member 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 8 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).

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 technical knowledge in the Validation space using a risk-based and science-based approach.
• 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 QEV 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 greenfield/brownfield 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.