US SpeCare Compliance Head

Sanofi•Framingham, MA

1d•$210,000 - $303,333

About The Position

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.

Requirements

Advanced knowledge of regulations applicable to Medicinal and Medical Device products for Human and Animal Use
In-depth knowledge of Pharmaceutical Operations / Biologics
Bachelors in Science
Business Partnering, Communication & Networking, Influence, act for change, commit to customers, cooperate transversally, strive for results, decision maker, lead teams, think strategically
Project management skills, Analytical Skills, Continuous Improvement, Quality & Risk Management
English

Nice To Haves

Master-Degree in Pharmaceutical Technology, relevant Life Sciences or Engineering preferred.

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.