Data Integrity Expert at Sanofi Aventis US LLC

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

03 Apr, 26

Salary

0.0

Posted On

03 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Integrity, Regulatory Compliance, Data Quality Checks, Training Development, Risk Assessment, Documentation Practices, Incident Investigation, Continuous Improvement, Computerized Systems Validation, Inspection Readiness, Data Reporting, Cross-Departmental Collaboration, Quality Culture, Attention to Detail, Communication Skills, Problem Solving

Industry

Pharmaceutical Manufacturing

Description

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. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Data Integrity Expert will ensure compliance with regulatory requirements and lead initiatives to enhance data integrity practices at the Tuas site. This includes conducting data quality checks, developing training programs, and overseeing the validation of computerized systems.