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Supplier Quality Lead - Cell & Gene Therapy

Waltham, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Rewards

  • HEALTH AND WELLNESS PROGRAMS

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • EMPLOYER MATCHING

    Employer matching because Sanofi invests in their employees!

  • PROFESSIONAL DEVELOPMENT

    Sanofi is eager to further your development and expertise in an ever challenging environment.

  • FAMILY SUPPORT

    Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.

  • PAID TIME OFF

    Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!

  • WORK/LIFE BALANCE

    Importance of life outside of the office is valued at Sanofi.

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Responsibilities

JOB DESCRIPTION

The Quality Lead – Cell/Gene Therapy provides quality oversight of GxP activities at third party facilities used in the production of Bioverativ’s cell and gene therapy products.  This individual works within a cross functional team and is responsible for oversight of manufacturing activities including, but not limited to, materials receipt, cell separations, cell culture, final formulation, packaging, labeling, inspecting, testing, release, shipping, associated Quality Assurance/Quality Control activities and documentation.  The Quality Lead – Cell/Gene Therapy ensures compliance with Bioverativ Quality Management Systems and regulatory requirements. Role requires some travel, primarily domestic.

MAIN RESPONSIBILITIES

  • Provide quality oversight of GxP cell/gene therapy production activities performed at external contractors
  • Oversee qualification of vendors; includes follow-upon on audit findings, audit responses (CAPAs, etc.)
  • Provide quality guidance and support for investigations and change controls
  • Provide support of process development and qualification activities including GxP document review and approval
  • Provide support of product stability programs including document review and approval
  • Perform review/approval of master production records, executed batch records and disposition of product; includes review of deviations, OOS investigations, and changes implemented during batch production
  • Provide quality support for clinical and commercial technology transfers (as applicable)
  • Provide quality input into technical and/or risk assessments that evaluate cell/gene therapy projects
  • Provide support of Bioverativ Quality Management Systems, as needed
  • Travel to contract facilities to support Bioverativ products, as needed
  • Participate in routine internal and external Operations Meetings
  • Escalate quality and compliance issues to quality management; coordinate activities with other GxP quality stakeholders, as applicable

QUALIFICATIONS

  • Experience working with external partners (e.g. CMOs, contract laboratories and suppliers); ideally experience working in a clinical (GCP) environment supporting investigator trials
  • Demonstrate strong leadership capabilities, but also the ability to actively listen
  • Experience with cell/gene therapy manufacturing processes
  • Ability to influence in a matrix organization
  • Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach         
  • Manage through ambiguity, work independently and prioritize the workload with minimal direction
  • Exude a passion for relationship building both inside and outside the company
  • Demonstrate excellent communication skills both internally and externally
  • Ability to multi-task and work in a fast paced and dynamic environment

EDUCATION

  • Bachelor’s degree is required. Masters is preferred or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position.
  • Minimum 8 years pharmaceutical / biotechnology industry experience. Demonstrated success in working cross-functionally in a matrix organization; minimum 4 years’ experience within a Quality role.

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-SG

#LI-GZ

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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