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Responsible for leading the QA support to shop floor operations in Meriden and Pearl River, for the release and approval of drug substance batches, and connecting with global Quality team that supports CMOs.Facilitates quality compliance systems and objectives. Manages staff to achieve goals and develop capabilities. Interacts with cross functionally with Manufacturing, QC, Regulatory Affairs, Validation, and Engineering.Participates in teams with intellectual honesty, insight and a supportive manner.Effectively anticipates and communicates issues and acts as required.Performs all activities in compliance with GMPs, SOPs, corporate policies and the highest ethical standards.Dimension/Scope:
Generates and publishes batch release metrics to site management.
Develops, maintains, evaluates and enhances procedures and processes in accordance with internal and external standards and requirements to maximize performance.
Collaborates counterparts to ensure alignment of methodologies and best practices.
The incumbent is expected to work independently with a level of autonomy to drive process improvements, ensure ongoing compliance to licensed requirements and current GMPs, and also achieve process efficiencies.
The position requires extensive communication with counterparts, Regulatory Affairs, Production, Planning, QC, CMO, and communication with R&D as required.
Excellent interpersonal, communication skills and GMP understanding are critical.
The position will be supporting the Product Quality Manager and will be working under the direction and guidance of Deputy Director Product Quality.
Basic Qualifications:
BS degree in science
Minimum 10 years' experience in the biopharmaceutical industry
Minimum 6 years' in a leadership role within quality assurance.
Must be well organized and able to effectively span the requirements of a small company QA organization
Demonstrated critical analytical and evaluation skills
Communicates effectively in English (written and verbal)
Training in quality control methodologies, i.e., control charting, investigations, etc.
Experience in commercial operations and regulatory health inspections
Preferred Qualifications:
Advanced degree
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.#GD-SP#LI-SPAt 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.
