Regional Quality Documentation Manager

Sanofi; Petaling Jaya; On-site; MYR 60,000 - 100,000; Full time

Job summary

Join a forward-thinking global life sciences company dedicated to improving healthcare access. In this pivotal role, you will lead a regional documentation team, ensuring compliance and driving process improvements in a dynamic environment. With a strong emphasis on collaboration and innovation, you will have the opportunity to influence the future of healthcare solutions. This company values your contributions and offers a comprehensive rewards package, including health benefits and opportunities for career growth. If you're ready to make a meaningful impact in the pharmaceutical industry, this is the role for you.

Benefits

Health insurance

Out-patient benefits

Maternity leave

Paternity leave

Solo parent leave

Qualifications

• 5+ years in documentation, especially in GxP environment, with team management experience.
• Strong analytical and problem-solving skills with attention to detail.

Responsibilities

• Lead and develop a regional documentation team, ensuring compliance with internal standards.
• Initiate process improvements and manage work processes efficiently.

Skills

Problem-solving

Attention to detail

Organizational skills

Analytical skills

Team management

Education

Bachelor’s Degree in Business Administration

Master’s Degree in Business Administration

Tools

Quality DMS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

About the Job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.

Main Responsibilities

1. Lead regional documentation team, surrounding documentation specialist and support.
2. Close exchange with other team leads (also on global level) and regional document manager.
3. Direct, motivate, coach, and develop team, conduct evaluation interviews.
4. Initiate and implement process and procedure improvement proposals, must be able to track regulatory changes.
5. Contribute to team effectiveness, identify risks, formulate improvements.
6. Manage work processes efficiently within the local laws & procedures, verify compliance of documentation process with internal standards & guidelines.
7. Interface to internal teams and corporate bodies.
8. Maintain a professional network and ensure a collaborative relationship with stakeholders.

About You

1. Minimum a Bachelor’s Degree or Master Degree in Business Administration or related field of study.
2. Minimum 5-years of working experience in documentation, especially in GxP environment, with at least 2-years of experience in managing a team.
3. Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner.
4. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.
5. Sufficient skills in Quality DMS, Word, Excel, Powerpoint.

Why Choose Us?

1. Bring the miracles of science to life alongside a supportive, future-focused team.
2. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
3. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
4. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including health insurance, out-patient benefits along with a range of family friendly policies such as maternity, paternity, and solo parent leaves to name a few.

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!