Quality Intelligence & Advocacy Lead

Sanofi • Framingham, MA

4d

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. Foster best-in-class performance by leveraging data, technology and diverse talents to secure product launches and support compliance through audits, inspections, regulatory surveillance, and advocacy. This critical role: Influences the development of external regulations, guidance, policy, and other initiatives that are external and relevant to Sanofi. Obtains Quality Intelligence through regulatory surveillance, benchmarking and participating in Trade and Industry Associations. Serves to clarify the existing regulatory framework to inform our internal compliance strategies. Drives Sanofi compliance to the current and new international GxP regulations and supports the compliance of Manufacturing Operations. Breadth of activities spans Sanofi enterprise and includes the pipeline and the commercial portfolio. Supports lifecycle activities for products including commercial (including post-approval commitments and post-approval changes), additional indications (line extensions), divestments. GxPs areas of Current Good Manufacturing Practice (cGMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP). Additionally, some assets have technology aspects, including medical devices, computerized systems, in-vitro diagnostic (IVD) and digital technologies including artificial intelligence, which are also considered in the scope of this role. Supports a diverse product portfolio across all GBUs; Specialty Care, Vaccines, General Medicines, and R&D. Defines, structures and implements Quality Systems in accordance with GxP and the Group guidelines. Provides tools and processes to support the implementation and the continuous improvement of the Quality System in his/her specific domain. International scope including major regulators with focus on US FDA (USA), but also includes EMA (Europe), MHRA (UK), PMDA (Japan), NMPA (China), ANVISA (Brazil), with a focus on the assigned region. 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

• B.A. or B.S. or equivalent required, preferably in science, pharmacy, engineering, data science, or related, but will consider all degrees.
• 9+ years relevant experience in the pharmaceutical, biotech, medical device, or related industries or at a major regulatory authority.
• Previous experience interfacing with Regulatory Authority Inspectors or Agencies from different regions of the world (e.g., US FDA, ANSM, PMDA, NMPA, EMA, MHRA, etc.).
• Knowledgeable in ICH guidelines revision process.
• Extensive knowledge of GxP topics including Quality Systems, and Compliance from major Health Authorities.
• Strong understanding of manufacturing processes, validation principles, risk assessment methodologies, and statistical techniques.
• Demonstrated ability to synthesize complex data into concise, actionable recommendations.

Nice To Haves

• Master's degree and/or PhD preferred in pharmacy, analytical sciences, (micro-)biology, engineering or equivalent.
• Member of Industry Associations (e.g., International Society for Pharmaceutical Engineering (ISPE), BioPhorum, BSI, Parenteral Drug Association (PDA,), and/or A3P etc.) with working group experience in authoring guidance documents and/or white papers preferred.
• Four or more years of experience as an auditor and/or inspector.
• Eight or more years of combined experience as an auditor and/or inspector and Site Quality Head.
• French speaking a plus.

Responsibilities

• Interfaces with Senior Quality Leadership as well as internal stakeholders in GRA (and other relevant departments) to align on strategic advocacy priorities and tactics.
• Executes Strategies for Quality Intelligence and Advocacy.
• Engages with regulatory authorities, industry, and professional association leaders at the policy level; leverages understanding of regulatory health authorities, industry trade associations, and other relevant organizations to advance Sanofi's position related to GxP topics
• Participates in GMP GDP Quality Council (IRISC) Governance Committee
• Ensures Sanofi engagement with external trade associations for critical Quality topics, and as a leader, represents Sanofi in key associations, and represents Sanofi at the assigned Trade Association (e.g., EFPIA, PhRMA, BIO, IFPMA, RDPAC, etc.)
• Performs regular surveillance on GxP topics relevant to Sanofi and ensures communication to internal stakeholders and Subject Matter Experts
• Assesses the potential impact of upcoming draft technical and regulatory changes, draft GxP documents, and emerging trends on the Sanofi GxP activities.
• Liaises with Subject Matter Experts to define impact and potential actions
• Leads Sanofi One Voice process with internal stakeholders and Subject Matter Experts for harmonized commenting on forthcoming guidance/regulations.
• Ensures harmonized processes across GBUs (M&S, R&D) for assessment of forthcoming regulations and support, including execution of gap assessments to new, adopted regulations.
• Leads and ensures a reliable Subject Matter Expert Network for all GxP critical topics
• Contributes to Sanofi Global Quality Standards and Procedures to ensure compliance to evolving regulations.
• Collaborates with internal stakeholders to establish Sanofi position and advocacy tactics for critical GxP topics.
• Represents Sanofi on key topics by presenting Sanofi position on key GxP topics at external industry conferences and events.
• Contributes to external publications.
• Utilizes data, technology to drive efficiencies, enhance insights, facilitate knowledge sharing, and simplification.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level