Director of QCTS (Quality Control Technical Services)
Who You Are
You are a dynamic Quality Control Laboratory 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
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 Director of QCTS is responsible to ensure compliant and efficient Quality Control operations. This position ensures that complex, explicit documentation for method validation protocols and technical reports are adherent to corporate standards and regulations and utilize appropriate experimental design and statistical analyses. Identify potential problems and proactively suggest technical solutions based upon analytical expertise and knowledge of product/process. Lead team to solve assay/analytically-related process problems. Determine technical objectives and approaches to assignment.
Function in a project leadership role, guiding the successful completion of major projects. Employ in-depth technical knowledge to define and manage laboratory studies on investigations of quality control procedures.
Contribute substantially to the understanding, application, and interpretation of results. Develop project strategy. Work with department head toward long-range goals and objectives. Assignments are often selfinitiated. Interface with external regulatory agencies as required.
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
- 8 to 10+ years of experience with people leadership (supervisory) responsibilities.
• Member in professional affiliations (e.g. 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.
- Advanced degree (Master’s or PhD) in a science or technical discipline.
Terms of Employment
Approximately 10% travel for site visits, vendor relationship management, conferences and training.
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.
Ability to gown for access to clean room and other sterile areas
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.