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JOB HIGHLIGHTS:Lead, Contract Manufacturing Operations Quality, Genomic Medicine Unit is a key role to provide quality 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)). The criticality stems from the significant number of Sanofi gene and cell therapy programs that are using third parties for GMP manufacture and testing.Provide quality 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))Manage the external quality team whose responsibilities are the following:
Manage the quality operations and compliance of the CMOs & CTLs to ensure timely disposition of clinical product.
Participate in regulatory inspections at the CMOs and CTLs in scope
Ensures quality issues emerging from projects be assessed, investigated and resolved
Ensures that batches record reviews, PSF data collections and compliance certifications for the cell therapy third party quality team’s associated activities are performed
Monitors the risk profile of external partners and subcontractors and measures and monitors key Quality performance indicators.
Participate in Due Diligence activities for prospective alliances and partnerships or acquisitions
Responsible for duties as part of the quality sub team for CMC cell and gene therapy projects and in certain instances be the Quality Project Team Representative
Other operational actions: To Manage quality alerts and other investigations.
Conduct external audits, self-inspections, due diligences.
Escalate quality issues and risks.
Responsible for travel to various contract facility sites as needed for CMO relationship/production management and/or Person in Plan, 20% Domestic and International
BASIC QUALIFICATIONS:
Ph.D., M.S., B.S. or other university or engineering degrees in one of the areas of pharmaceutical drug development (e.g., Pharmacy, Chemistry, Biochemistry, Biotechnology or closely related discipline)
A minimum of 4 years work experience in the Pharmaceutical Industry with at least 2 in a quality environment.
A minimum of 2 years work experience with Cell or Gene Therapy or Biologics.
PREFERRED QUALIFICATIONS:
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 alliances/partners.
Experience in leading a team and managing direct reports.
Good knowledge of development processes applied to R&D projects / alliance partnerships and of being a member of CMC sub-teams.
Familiarity with all processes associated with batch releases (review of batch records, COA's, COC's CAPAs, deviations, change controls, etc), quality agreements and audits and must be fully conversant in at least one quality area.
Experience of working in a cross-functional team-oriented organization, across geographies in multiple countries.
Ability to propose innovative, pragmatic and creative solutions to complex problems, ability to take a holistic view and anticipate impacts from a global perspective Experience in Quality System management.
# years of experience with GxP (at least one core)
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 (in particular in the CMC related field)
Strong problem-solving skills
Strong communications skills
Proactive and innovative mindset
Change agent.
Fluent in English
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.#GD-SA#LI-SAAt 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.
