Qualification & Validation Manager, Report Issuance

Job title: Qualification & Validation Manager, Report Issuance

• Location: Hyderabad

• Grade: L2-2

• Hiring Manager: Abhijeet Shingate

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:

• Provide strategic direction to the global qualification team, aligning activities with company goals and regulatory requirements. Oversee daily operations of qualification activities, ensuring timely and accurate completion of tasks and overall performance. Drive continuous improvement initiatives within the qualification processes and methodologies.

• Mentor, coach, and develop team members, conducting performance evaluations and facilitating professional growth. Act as the liaison between the qualification team and the global hub leadership team, ensuring alignment and effective communication. Align with global quality team and ensure that all documentation standards are applied.

• Oversee the preparation, review, and approval of qualification protocols and reports, ensuring accuracy and completeness. Deliver high-quality service to internal customers (sites), addressing their needs and expectations. Maintain collaborative relationships with key stakeholders to ensure smooth execution of qualification activities.

• Apply and align documentation standards with global quality team. Prepare, Review qualification protocols, reports, and documentation for accuracy, completeness, and compliance. Collaborate with cross-functional teams, including Quality Assurance, and Engineering, to ensure alignment and consistency in qualification practices. Provide training and support to team members on compliance-related topics and best practices.

About you:

• Experience: >5 years professional experience in qualification and proven leadership track record.  

• Soft skills: 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. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments.   

• Technical skills: Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point.

• Education: Master’s or Bachelor’s degree in pharmacy, Chemistry, Engineering or a related field. Advanced degree (e.g., PhD) preferred.

• Languages: Excellent English communication and writing, French or other Languages in addition preferred

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Opportunity to work in an international environment, collaborating with diverse business teams and vendors, working in a dynamic team, and fully empowered to propose and implement innovative ideas. 

Abhijeet Shingate, Qualification & Validation Lead - Report Issuance

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!