Sanofi Group Manager Quality Control Microbiology in Canton, Massachusetts

Job Overview:

  • This position is to manage the QC Microbiology activities in the Canton QC department. The individual will manage all operational activities related to environmental and utilities monitoring and product testing programs.

Responsibilities:

  • In coordination with lab management provide technical/functional leadership to lab personnel. Manage daily utility and environmental monitoring and microbial testing for the manufacturing facilities in a cGMP compliant manner.

  • Accountable for maintaining laboratories in a cGMP compliant and inspection-ready state.

  • Create/review/update SOP’s for the functional area and author/review documents related to cross functional activities as necessary.

  • Mange the routine maintenance activities of lab equipment and support utilities. Manage all external testing activities.

  • Manage OOS/OOT and other deviations. Manage Change controls and CAPA’s related to the functional area.

  • Supports regulatory, corporate and internal inspections as required.

  • Initiate and maintain continuous improvement processes in the Microbiology area of QC.

  • Manager level. No direct reports, responsible for management of laboratory processes and workflow.

Sanofi Pasteur SA 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.

Requirements and Qualifications:

  • BS/MS in Microbiology or Biology

  • 7+ years of specific job-related experience in the pharmaceutical/biopharmaceutical/medical device industry in a cGMP environment is required.

  • Expertise in Microbiological methodology including hands on testing and interpretation of compendial test methods and regulatory guidance to ensure compliance with industry standard EM and microbiology processes.

  • Experience with personnel/workflow management and technical mentoring

  • Hands-on experience in routine microbiology tests such as Bioburden, LAL, sterility, TOC and conductivity testing, environmental monitoring and microbiological identification.

  • Computer skills in Office productivity tools.

  • Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization

  • Excellent organizational and interpersonal skills

Terms of Employment:

  • Standard First Shift (M-F, 8-5)

  • Will not have direct reports, but will be responsible for coordinating personnel activities with deputy director

  • Minimal travel required

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.