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Job Title: Lead GMU Technical Operations
Location: Framing, MA, Waltham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The purpose of this position is to provide quality technical management oversight of Sanofi sponsored GMP manufacturing and testing of genomic medicines at third parties (Contract Manufacturing Organizations (CMOs) and/or Contract Testing Laboratories (CTLs)). 

Focus on growth:

• Secure release cycle time by process optimization and focus the effort on where we have real quality risks and decrease workload through innovation and support of simplification
• Anticipate and remediate supplier and CMO risks

Accelerate efficiency:

• Anticipate and remediate supplier and CMO risks

Reinvent how we work:

• Role model a proactive Quality mind-set by implementing new operating models and continuous improvement culture
• Enhance partnership with operational unis and across all responsible sites

Lead with innovation:

• Enhance partnership with operational unis and across all responsible sites

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Key Contributions & Activities:

Manage all quality technical activities associated with GMP manufacturing and testing of genomic medicines.  Specifically, to lead the following activities: 

• Manage the quality technical operations as a SME and compliance of the CMOs & CTLs to ensure timely disposition of clinical product.
• Active member of the GMU platform leadership team providing Quality direction to the head of GMU operations.
• Participate in regulatory inspections at the CMOs and CTLs in scope. 
• Monitor the risk profile of external partners and subcontractors ensuring that proper mitigation is in place by providing current regulatory guidance or requirements (i.e., ICH Q9, Annex 3, Annex 13, Eudralex Vol 4 GMPs specific to ATMPs). 
• Conduct external audits, self-inspections, and participate in due diligences activities for prospective alliances, partnerships or acquisitions. 
• Guide the quality sub team as SME for CMC GMU projects and in certain instances be the Quality Project Team Representative. 
• Able to identify, escalate, and manage quality alerts and other critical investigations.  To rapidly and properly assess SISPQ.
• Responsible for travel to various contract facility sites as needed for CMO relationship/production management and/or Person in Plant, 20% travel, Domestic and International.
• Lead with innovation: support a Quality framework for new products with development phase adapted approach and defining the guiding principles on quality requirements for new product launches from end to end.
• This position is critical to develop and lead a first-class Quality support team for Genomics Medicine R&D operations from preclinical to submission to launch Sanofi’s cell and gene therapy portfolio.

Scope of Responsibility:
Latitude of action

• All GMU Manufacturing Platform sites: Waltham, Framingham, and contract organizations (CMOs).

Role impact:

Critical

• The person in role provides support and quality partnership as a SME with Business Development, MCCQ, CMC external collaboration, Alliance Management, and Legal for Due Diligence activities.
• The person in role liaises with and between partners/CMOs/CLOs, and all R&D quality representatives involved in the project; as well as makes the link with R&D SQO Management as needed to support technical challenges.

• The incumbent plays a key role in leading and coordinating R&D quality strategy for assigned projects, and links to the CMC development project strategy and objectives and gives guidance as the expert for GMU DS point of view.

Scope

• Sanofi R&D Sites/ platforms, interactions with CMC, R&D Vaccines, Global Quality, Alliance Management, Global Regulatory Affairs, Clinical Supply Operations, Business Development, Legal, Project Teams, Sanofi M&S Sites/platforms, and external partners

HSE

Is responsible for the implementation of the group / site HSE policy at the level of its scope of activity:

• Ensures the safety of people and goods by respecting the safety rules in force in the company.
• Respects and enforces the rules in accordance with the Group's HSE policy.
• Ensures the proper management of risks (e.g., biological, chemical, radioactive, ergonomic) according to its activity (s); takes the necessary hygiene precautions to minimize the risk to which it is exposed and ensures, where appropriate, the integrity of the study; warns the competent persons of any state of health or affection of which they are aware.
• Ensure the security of the assets (documents, premises, equipment) in accordance with the rules in force in the Group.
• Promotes the right actions for the environment.

About You

Required Skills:

Potential Specific Domains:

• Subject matter expert in Gene Therapy DS manufacturing
• In-depth knowledge of quality regulations and guidelines applicable to R&D pharmaceutical activities.
• Excellent interpersonal, communication, and facilitation skills since this position requires frequent direct interaction with and appreciation for the relationship side of our R&D partners, CMOs, CLOs.
• Must have good knowledge of development processes applied to Sanofi R&D projects/ partnerships, CMOs, CLOs and of being a member of CMC sub-teams.
• Must be familiar with all processes associated with batch releases (review of batch records, COAs, COCs, CAPAs, deviations, change controls, etc.), quality agreements, and audits.
• A good understanding of all areas of the Sanofi businesses beyond pharmaceuticals (including vaccines and commercial) is a distinct advantage.
• Thorough understanding of contamination control and sterility assurance regulatory requirements and industry best practices.

Education & Professional Experience:

• B.S. Engineering in one of the areas of pharmaceutical drug development (e.g., Engineering, Pharmacy, Chemistry, Biochemistry, Biotechnology, or closely related discipline plus 10 years of experience in a pharmaceutical or GMP environment with at least 6 years in a quality environment – required. – M.S./MBA plus 6 years of experience or Ph.D. with 4 years of experience would be considered.
• 2+ years of work experience with Cell or Gene Therapy – required.

Core Competencies:

• Strong knowledge of cGMP / ICH / FDA / EMA regulation; strong background with specific regulations and guidance for DS manufacturing.
• Deep understanding of GMP and CMC requirements by health authorities and experience in preparation and reviews of regulatory dossiers and interactions.
• Excellent written and verbal communication skills, and ability to influence at all levels across internal and external network including Development, Manufacturing, Engineering, Digital, Quality, Procurement, RA-CMC and finance.
• Excellent management, communication and interpersonal skills.
• Project management (experience in working in project team and in complex environment, dealing with leading international and/or multi-cultural teams)
• Research & Development activities and processes (specifically in a CMC related field)
• Risk Management methodology
• Change agent English: Fluent professional practice

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.