Expert II, (Computer System Validation), Quality (Modulus Singapore)

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. 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 Modulus facilities is constructed in Singapore at 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.

As an Expert II, (Computerized Systems Validation) QA you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system [EMS], laboratory information management system [LIMS], batch record management systems [MES], Data Historian), Process Control Systems (e.g., distributed control system [DCS], programmable logic controller [PLC]), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems. You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.

Key Accountabilities

• Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.

• Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.

• Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.

• Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.

• Author CSV plans and procedures.

• Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory.

• Ensure continual improvement of CSV program by performing periodic review of the program.

• Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.

• Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.

• Provide support during regulatory inspections and site audits as quality oversight and SME of CSV.

• Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.

About You

Education and experience

• Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields. 

• A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.

Key technical competencies and soft skills:

• Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.

• Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.

• Solid technical knowledge in the use and application of risk- and science-based approaches to CSV.

• Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.

• Good communication skills to present validation strategies to the site management and other functions.

• Experience in greenfield/brownfield facility start-ups will be advantageous.

• Familiar with Digital 4.0 concepts and potential applications in Quality.

• Able to work independently with little supervision.

• Experience with ensuring Data Integrity in computerized systems.