Quality Business Owner (Deviation System Owner)

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading global healthcare company in Singapore is seeking a qualified individual to oversee their Deviation system and quality processes. The ideal candidate will have 7-10 years of relevant experience in the pharmaceutical or biotechnology industry, coupled with strong data analysis and communication skills. This role requires ownership of quality processes, supporting audits and inspections, and developing training programs. By joining our team, you will contribute to pioneering healthcare solutions through innovative manufacturing practices.

Qualifications

• Minimum 7-10 years of relevant experience in the pharmaceutical or biotechnology industry.
• Ability to analyze complex data sets and identify patterns.
• Effective training and communication skills.

Responsibilities

• Own the Deviation system for the site and address quality issues.
• Conduct regular data quality checks and validations.
• Develop and deliver training programs.

Skills

Data analysis

Verbal communication

Written communication

Team collaboration

Digital 4.0 familiarity

Education

Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related fields

Job 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.

Main Accountabilities

• Being the Business Owner of Deviation system (including Quality Escalation, Alert, Complaints and Recall) for the site. Owning process, system, and data
• Conducting regular routine data quality checks and validations to identify and address any process, system, or data issue
• Developing and delivering training programs principles and practices
• Identifying and assessing risks related to the process in scope and implementing mitigation strategies
• Leading continuous improvement initiatives on site, in line with global processes and practices
• Overseeing the computerized systems associated with the process to ensure they meet all requirements
• Establishing and monitoring key performance indicators in line with global guidance
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
• Representing Sanofi global quality when interacting with health authorities for global processes
• Establish and prioritize process evolutions for the site
• Support audit and inspection and present the process to auditors and inspectors
• Proactively identify remediation actions from findings from internal and external audits
• Identify training needs

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.

Expected Technical Skills

• Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement
• Strong verbal and written communication skills to effectively train staff, report findings, and collaborate with various departments
• Very good communication skills to be able to face audit and inspections

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!