Data Integrity Expert

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 Tuas (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 Data Integrity Expert, you are to work closely with the respective Tuas functional teams to provide oversight and guidance for data integrity and projects related to data integrity to achieve the site’s digital ambition while in compliance with data integrity requirements. In addition, this role will lead the site self-inspection program to ensure the key compliance principles are embedded in the site processes and practices. He/she will also lead the site Quality Culture program, enabling the right Quality Culture to be embedded.

Main Accountabilities:

• Ensuring compliance with regulatory requirements and company policies related to data integrity

• Conducting regular routine data quality checks and validations to identify and address any data integrity issue

• Developing and delivering training programs on data integrity principles and practices

• Identifying and assessing risks related to data integrity and implementing mitigation strategies

• Ensuring proper documentation practices are followed, including data recording, storage, and retrieval

• Investigating data integrity incidents, including potential data breaches or falsification incidents, and implementing corrective and preventive actions (CAPA)

• Leading continuous improvement initiatives to enhance data integrity practices

• Overseeing the validation of computerized systems to ensure they meet data integrity requirements

• Ensuring inspection readiness and participating in regulatory inspections and audits related to data integrity

• Generating and reviewing data integrity reports and metrics for management, especially the DIMM (DI Maturity Model)

• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication

• Establish and prioritize data integrity objectives for the site

• Proactively identify remediation actions from findings from internal and external audits

• Identify training needs and content for data integrity

• Decide on corrective and preventive actions for data integrity issues

• Advise on cross-departmental data integrity strategies

About You

Education:

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

Expected Experience:

• A minimum 7-10 years of relevant experience in the pharmaceutical or biotechnology industry.

• 5 years of experience in ensuring compliance with regulatory requirements related to data integrity in the pharmaceutical industry.

Expected Technical Skills:

• Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement

• High level of accuracy and attention to detail in data recording, auditing, and reporting

• Strong verbal and written communication skills to effectively train staff, report findings, and collaborate with various departments

• Proficiency in identifying root causes of data integrity issues and developing effective corrective and preventive actions

• Expertise in using and validating computerized systems and software relevant to data integrity management
  

Soft Skills:

• 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 strategies to the site management and other functions.

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

• Able to work independently with little supervision.