Global Quality Genome Platform Head

The Team:

The R&D Quality Operations department is a vital part of our business, thus an essential component to ensure the products arrive in good condition into the customer’s hands. Support growth of key products & secure supply by achieve on-time release, drive compliance remediation programs, anticipate supplier and CMO risks (e.g., supplier mono sourcing exit program, nitrosamines/ICHM7..) Enable launch of 30 products by 2028 by defining a clear Quality framework for launch units (e.g.: global guiding principles on quality requirements for new products at launch units, from end to end). Ensure inspection readiness by creatively solving problems with modern, flexible & sustainable solutions and build expertise on new techno & modalities.

The Role:

The Head of R&D Quality Genomic is responsible and accountable for all quality activities related to the Genomic Platform. The latitude of actions including all GMU Manufacturing Platform sites: Framingham, Lyon Gerland, Kiadis Amsterdam, contract organizations (CMOs). Leads and manages the Quality strategy within the R&D Genomic site’s network to ensure that drug development and manufacturing activities are following the Global Quality standards and applicable regulatory requirements and GMP principles as appropriate.

*Focus on growth: Secure release cycle time by process optimization and focus the effort on where we have real quality risks and decrease workload (Minor dev…). Anticipate and remediate supplier and CMO risks

*Accelerate efficiency:Simplify, harmonize the processes across the platform and …then digitize Quality

*Reinvent how we work: Equip your team with the skills/capabilities needed for future success. Switching to 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: Define a clear 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.

Job Highlights:

• Leads implementation of the Sanofi Quality Policy and the Quality systems in R&D Genomic.
• Integrates risk management principles into Quality systems, develops and supervises Quality programs and ensures inspection readiness in all responsible sites.
• Defines and develops the quality organization by ensuring optimal use of resources, development of competencies and appropriate interfaces within the company
• Assesses performance of Quality Management in conjunction with operational management.
• Ensures appropriate training and support for the preparation and realization of inspections in the sites and development units
• Ensures appropriate quality input and support for business projects, e.g., new business integration.
• Ensures the implementation of annual quality programs in a multi-year plan.
• Drives continuous improvement of the Quality concepts, promotes innovation, best practices, and system performance in their operational area.
• Ensures adequate relationship with regulatory authorities.
• Ensures quality reviews in the sites or units of his/her area of responsibility.
• Provides direction to his/her teams and professional pharmaceutical advice to other functions e.g. business development
• Organizing Quality networks to assist in sharing of information, identification of best practices and actions on continuous improvement.
• Leads specific Quality topics, as agreed with the Head of R&D Quality Operations, that impact across Global Quality Operations.
• Develops direct reports, find opportunities for career advancement. Provides education for pharmacist trainees. This includes regular training and education of Pharmacists / Qualified Persons to assure respective standards and regulations of the pharmaceutical industry are met.
• Leading a team about around 35 people.

Basic Qualifications:

• Ph.D. or advanced degree in Engineering, Life Sciences, Pharmacy, or related field.
• A minimum of 15 years of experience in Quality support and GMP operations with a strong background in Quality Control and Quality Assurance for the biopharma industry, including biologics and cell & gene therapy.
• 5 years’ experience as a People manager
• 3-5 years’ experience in CMC operations requirements
• Strong knowledge of cGMP / ICH / FDA / EMA regulation; strong background with specific regulations and guidance for cell & gene therapy
• Has lead health authority inspections and experience in preparation and reviews of regulatory written dossiers and interactions

Preferred Qualifications:

• 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, ability to set ambitious goals, communicate & align priorities across the organization
• Demonstrated ability to organize people and work to deliver on ambitious targets
• Demonstrate the ability to communicate and effectively interact with people across cultures

Key Points:

• Ability to travel (U.S./ Int’l) on occasion (<15% expected)

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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