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A Range of Possibilities

Quality Control Manager

date posted 11/21/2020
contract type Full time
job id R2571118
location Waltham, Massachusetts

External Supply Quality Control Manager(CLO oversight)

Job Description 

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

  • Oversee testing programs including: Assay Controls, Reference Standards, Product Release, Stability  

  • Oversees budgeting for CLO’s; including contracts and purchase orders

  • Support and facilitate deviations and investigations

  • Support long-term planning of QC lab capabilities and capacity

  • Responsible for coordinating with AD for the implementation of new technologies into CLO network

  • Change notification management

  • Data entry into LIMS

  • Data analysis for release data

  • Coordination and drafting of Annual Product Review sections

  • Coordination of Annual Method Reviews

  • Coordination/review of compendial methods for compliance

  • Active participant in the management and direction of the overall QC programs and requirements

Education

  • BS/MS in a scientific discipline with a minimum of 10 years experience in a GMP regulated industry (e.g. pharmaceutical or biotechnology). 

  • Experience managing contract laboratory organizations (CLO’s) preferred. 

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.

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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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