External Supply Quality Control Manager(CLO oversight)
The Lead/Leader for CLO oversight is responsible for managing all QC in-process, release, and stability activities for clinical and commercial products. The candidate will be responsible for relationship management, CLO selection, and CLO strategies. Responsibilities also include liaising with the Analytical Development (AD) group to ensure appropriate oversight of method transfers and validation activities. This position works closely with Operations, Quality Assurance, and Regulatory Affairs to develop and maintain a comprehensive program that ensures consistent quality throughout the production platform and lifecycle.
Qualifications and Technical Skills
Responsible for external quality testing at CLO’s (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs
Maintains relationships with CLO’s to ensure Quality Agreements, Statement of Work (SOW), and Manufacturing Service Agreements (MSA) are initiated and updated accordingly
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.
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