Expert II, Quality Assurance (Contamination Control & Sterility Assurance) EVF

Mission

Sanofi 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, 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 one Expert II, Quality Assurance (Contamination Control & Sterility Assurance) EVF 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 Expert II, Quality Assurance (Contamination Control & Sterility Assurance) EVF will be accountable for establishing and maintaining an effective contamination control/sterility assurance program for the site, based on quality risk management principles and according to Sanofi standards, to prevent contamination (e.g., microbial, viral, particulate, etc.). The role will be responsible for ensuring that effective control measures to reduce any risk of contamination have been identified and implemented. The role shall oversee the validation of sterilization / decontamination / sanitization / aseptic processes, utility and environmental monitoring, and facility cleaning and disinfection program. As a subject matter expert, the QA Expert, Contamination Control & Sterility Assurance shall provide guidance and technical expertise in contamination investigations, establishing contamination control strategy, performing contamination risk assessments and shall support in facilitating trainings and inspection readiness activities.

Key accountabilities include:

• Lead and/or provide quality oversight for designing, establishing, and maintaining site’s contamination control/sterility assurance program in accordance with regulatory expectations, Sanofi standards, and industry practices.
• Be the Subject Matter Expert (SME) on contamination control. As the SME, contribute to the development and implementation of Contamination Control Strategy (CCS) for the site and establish contamination control procedures for the site.
• Provide quality oversight to validation/qualification and continued verification of sterilization / decontamination / sanitization / aseptic processes, process closure, container closure systems, environmental monitoring, cleanroom gowning, and facility cleaning and disinfection program.
• As contamination control SME, support in the qualification of single-use systems, facility, clean utilities, raw materials, process hold times, reuse lifetime, analytical methods (for product, environment, utilities, cleaning samples testing), through review of commissioning and/or qualification documents (e.g., user requirements specifications, engineering drawings, qualification plans, protocols, procedures) and participation in design reviews.
• Provide quality oversight of site’s utility and environmental monitoring program.
• Establish risk based approaches and methodologies for the evaluation of contamination risks and prevention of contamination.
• Lead and/or support, through risk facilitation and/or participation, or as an SME, quality risk management activities including, but not limited to the following: products and processes microbial (including viral) and endotoxin risk assessments; process closure risk assessment; environmental monitoring risk assessment; selection of cleaning and disinfection agents.
• Work in close collaboration with stakeholders to implement appropriate controls to eliminate and/or reduce any identified contamination risks.
• Provide quality oversight of environmental/utility monitoring excursion and aseptic process simulation failure deviations, CAPAs, and investigations.
• Actively participate in inspection readiness activities to ensure a compliant and robust contamination control program.
• Partner with learning team to design and roll out awareness and competency-based learning program for site personnel, related (but not limited) to: contamination control; personnel hygiene and cleanroom behavior; sanitation/aseptic practices; decontamination (including sterilization); cleaning and disinfection.
• Partner and collaborate closely with cross functional teams to achieve the EVF SG site operational goals/objectives.

Education and experience

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Microbiology or related Life Sciences or Technology fields.
• At least 7-10 years of relevant experience working in the biopharmaceutical industry (preferably in vaccines and/or biologics), and at least 4 years’ experience with contamination control or sterility assurance.

Key technical competencies and soft skills:

• Sound knowledge and in-depth understanding of regulatory requirements and industry best practices (e.g., ISO, ASTM, ISPE, PDA) pertaining to contamination control and sterility assurance.
• Experience in developing and deploying contamination control/sterility assurance and environmental monitoring program for a facility.
• Experience in biologics and sterile manufacturing is desired.
• Strong working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and their application to contamination risk management.
• Working knowledge of data/trend analysis techniques.
• Experience in root cause analysis and leading investigations.
• Experience leading and working with cross-functional teams (both local and international).
• Strong interpersonal relationships to establish the partnerships necessary for the development of an engrained Quality Culture.
• Discipline and assertiveness in decision-making and implementation of validation strategies.
• Good communication skills to escalate and present potential risks and issues to the site management and other functions and advocate site positions during inspections
• Sound practitioner of Manufacturing 4.0 mindset (or equivalent Lean or Agile methodology).
• Familiar with Digital 4.0 concepts and potential applications in Quality.
• Experience in greenfield/brownfield facility start-ups will be advantageous.