Sanofi QC Microbiology Team Lead – Framingham, MA
Exciting Career Opportunity in Quality Control Microbiology!
Looking for a leadership role in Quality Control? Sanofi is hiring a QC Microbiology Team Lead in Framingham, MA. This position offers the chance to lead a dynamic team, oversee laboratory operations, and ensure compliance with CGMP standards. Ideal for professionals with experience in microbiology, lab investigations, and regulatory compliance. Apply now to advance your career in a global healthcare company!
Department Description
Quality Control (QC) is responsible for testing intermediate production samples, final product samples, and environmental samples to ensure compliance with CGMP standards. Other responsibilities include raw material testing, stability testing, assay transfers, and instrument qualification.
The QC Operations team supports laboratory investigations, deviations, CAPA, training, and change controls. QC Validation Support consists of the Method Validation Group and the Equipment Qualification Group. The department also supports site-wide studies and projects.
- Provide motivation, inspiration, and feedback to staff.
- Manage and coordinate studies and projects.
- Act as the primary contact for the team, liaising with other departments.
- Represent the functional area in meetings and compliance activities.
- Troubleshoot routine equipment and method issues.
- Participate in manufacturing scheduling meetings.
- Support internal and external audits.
- Coordinate daily scheduling and assignments.
- Perform and review assays as needed.
- Author and review technical documents and protocols.
- Assist in interviewing and onboarding new hires.
- Act as Document Owner for SOPs and maintain periodic reviews.
- Conduct daily QDCI/DCM meetings.
- Support QC Management team.
- Complete Phenix Laboratory investigations, Deviations, CAPA, and Change Controls.
- Ensure timely escalation of critical issues.
- Maintain positive relationships and effective communication across sites.
- Train junior employees.
- Ensure all safety requirements, including PPE and waste disposal, are met.
- Drive continuous improvement initiatives.
Basic Qualifications:
- Bachelor’s degree or equivalent with 4+ years of Quality and/or Operations experience in a CGMP laboratory.
- Associate degree/High School Diploma with 8+ years of experience in a CGMP laboratory.
Preferred Qualifications:
- Bachelor’s Degree in a science or technical field.
- Experience with scientific and technical writing.
- Knowledge of CGMP regulations (US, EU, and other regulatory agencies).
- Strong computer, verbal, and written communication skills.
- Effective time management, organizational, teamwork, collaboration, and leadership skills.
- Experience with Phenix or other investigation systems.
- Experience in a GMP lab environment and lab-based data management systems.
- Attention to detail.
- Work in a laboratory setting with minimal use of chemicals.
- Ability to lift 10 lbs.
- Be part of a supportive, future-focused team.
- Access growth opportunities through promotions and international roles.
- Competitive rewards package recognizing your contributions.
- Comprehensive health and well-being benefits, including 14 weeks of gender-neutral parental leave.
Equal Employment Opportunity
Sanofi and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to diversity and inclusion. We consider all qualified applicants regardless of race, color, creed, religion, national origin, age, gender, gender identity, sexual orientation, disability, veteran status, or any other protected characteristic.
