Associate Director of QC Microbiology
Who You Are
You are a dynamic Quality Control Laboratory professional interested in challenging the status quo to ensure seamless supply of life sustaining biologic therapies.
You are a valued influencer and leader who has contributed to the digital evolution of a QC organization.
You have a keen eye for improvement opportunities and the demonstrated ability to deliver on these opportunities using LEAN principles.
Who We Are
The Quality Control Framingham Hub organization supports the Quality Control Biologics
network globally in the area of Quality Control Technical Services (QCTS) and stability and
statistics support. In addition, the Analytical Hub Quality Control department provides compliant and timely testing support for various products, as well as facility environmental and critical utility monitoring.
Where We Are
Our facility is in Framingham, Massachusetts and serves as the regional hub for development, testing, and release of Sanofi products.
Framingham is a suburban/rural community located about 20 miles east of Worcester and 25 miles west of Boston in beautiful, affordable Central Massachusetts with convenient highway access.
The Associate Director of QC Microbiology is responsible to ensure compliant and
efficient Quality Control operations. This position ensures alignment with evolving corporate and global laboratory standards, quality system element remediation, regulatory inspection information, and best practices resulting in robust inspection readiness. This role provides support to the broader Framingham Biocampus as it relates to Environmental Monitoring and Critical Utility Monitoring. Supports key stakeholders during internal and regulatory inspections as it relates to the area of support provided to these key stakeholders.
In addition, this role provides oversight to the sample management staff ensuring on-time sample delivery and sample log-in within QC as well as maintenance of general QC support activities (e.g. autoclave, glass washer operations).
This role also ensures a focus on maintaining a strong safety and compliance culture. Reports to the North America Analytical QC Hub head with people leadership responsibilities for staff of 7 to 10 scientists.
- Bachelor’s Degree in a science or technical discipline
- At least 10 years of experience in the pharmaceutical/biotech industry
- At least 5 years of experience with people leadership (supervisory) responsibilities.
• Member in professional affiliations (e.g. American Society for Microbiology, PDA, etc.)
• Demonstrated success in leading organizational and cultural change. Demonstrated
success in leading organizational and cultural change.
• Lean Transformation Experience.
• Experience and Working Knowledge with SMS / Lean tools.
SMS / Lean Certification.
Bachelor’s Degree or higher in Microbiology
Terms of Employment
Approximately 10% travel for site visits, vendor relationship management, conferences and training.
Ability to gown and enter Quality Control laboratories and Clean Room spaces
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.
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.