Job title: US SpeCare Compliance Head

Location: Framingham, MA

 

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Provide oversight of cGMP Compliance within the M&S SpeCare GBU. Lead cGMP Compliance projects within the M&S SpeCare GBU Quality Operations through transversal activities across the network of sites. Support sites inspection readiness and assess implementation of Sanofi’s Quality Management Systems at site level in accordance with the company and applicable regulatory requirements.

Coordinate the M&S SpeCare QO governance and manage the reporting activities of key quality indicators (KPIs) across the sites to monitor performance and continuous improvement.  Liaise and network with counterparts in other GBUs, Sanofi Quality Business Process Owners (BPOs) for key transversal compliance topics to achieve synergies and consistencies for implementation of compliance approaches and quality systems.

Latitude of Action:
This position reports solid line to the M&S SpeCare GBU Quality Operations Head.  The role holder is required to work autonomously taking decisions in line with Sanofi Global Quality Policy, Standards, Procedures and Processes. The role holder is highly independent strategic thinker and has strong compliance mindset; results-driven, can-do-attitude, solution-oriented, change-agent, patient centric mindset, innovative and resourceful.

Role Impact:
The role provides a key link between the Site Quality Units, the related M&S SpeCare GBU Quality Unit and Global Operational Quality Units. It is a key role in ensuring coherent development and roll-out of the Sanofi Quality Management System in line with regulatory requirements, Pharmaceutical Quality System ICH Q10 and Sanofi quality policy across the managed manufacturing sites’ network.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Lead cGMP compliance projects in line with the M&S SpeCare GBU Quality Operations strategy and priorities
• Support sites’ inspection readiness through on-site quality system assessment, gap identification and support for mitigation action plan development
• Support external inspection readiness providing the assistance and guidance in inspection preparation, training on inspection management process, coaching during inspections and inspection response management and follow-up on the corrective and preventive actions.
• Support the Cluster Quality heads in reviewing the effectiveness of the sites’ Quality Systems and Quality Program during site visits, and interactions with the sites on Quality and GMP Compliance matters or appropriate alternative contacts (example: tele-conference or web meeting), with systematic provision of either visit reports or meeting minutes to record items agreed and actions planned.
• Contribute to the Global Quality Dashboard, when necessary, ensuring accurate data reporting to M&S SpeCare GBU Operations Management and Global Quality.
• Coordinate the IRISC activities for the M&S SpeCare GBU. 
• Provide leadership with respect of quality culture, quality mindset and quality cGMP compliance performance and continuous improvement engaging all functions and organizational levels across the M&S SpeCare GBU.
• Support Cluster Quality Heads to ensure that the sites' Quality units are adequately trained in Sanofi Global Quality System and Regulatory requirements and providing/organizing as appropriate training on site, including inspection readiness training when assigned.
• Organize webinars supporting Quality network information exchanges and sharing lessons learned and best practices for key transversal quality topics.
• Quality Risk Management: as appropriate, provide support to the Cluster Quality Heads with respect to risk management and ensure that quality risks are properly managed (assessment, control, communication.)
• Contribute to the Risk Management Report and support the review of corrective and preventive actions.
• Contribute to the digital roadmap transformation aligning with Global Quality strategy through appropriate communication with sites and active participations in business operating committees for key global solutions.
• Contribute to the development, revision, and promotion of Sanofi Global Quality Documentation
• Liaise and networks with Cluster Quality Heads and compliance experts in other GBUs, global quality BPOs and Quality Systems Owners, and other operational functions.
• Coordinate with Global Quality Communication to facilitate efficient communication of M&S SpeCare QO.

Management Responsibilities:

This position has no direct reports. This position interacts with:

• Cluster Quality heads and PQL within M&S SpeCare GBU
• Site Quality Managers
• Operational functions within M&S SpeCare GBU
• Global Quality functions including the quality technical experts and quality business process owners (BPOs).
• This position also networks with QO heads and compliance experts in other GBUs.

  

About You

•  Experience: Advanced knowledge of regulations applicable to Medicinal and Medical Device products for Human and Animal Use; In-depth knowledge of Pharmaceutical Operations / Biologics.
• Education: Bachelors in Science.  Master-Degree in Pharmaceutical Technology, relevant Life Sciences or Engineering preferred.
• Soft skills: Business Partnering, Communication & Networking, Influence, act for change, commit to customers, cooperate transversally, strive for results, decision maker, lead teams, think strategically. 
• Technical skills: Project management skills, Analytical Skills, Continuous Improvement, Quality & Risk Management  
• Languages: English 

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$210,000.00 - $303,333.33

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.