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Associate Director, Manufacturing Specialists

Company: Sanofi Group
Location: Framingham
Posted on: May 3, 2021

Job Description:

Shift will either be 5 x 8 hours or 4 x 10 hour shift positionLooking for those with strong cGMP including pharma/bio or medical devicesOrganized individual with prior/strong Project Management skills and a Team MemberVaccines/BiologicsPOSITION OVERVIEWSanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients needs. Working within the Framingham Site in the Specialty Care Division of Sanofi Industrial Affairs, the Manufacturing Specialist organization supports the production of multiple commercial drug substance manufacturing processes across the Framingham Biologics Bio campus. The scope of the manufacturing specialist organization includes the management of change process for commercial manufacturing operations and the manufacturing instruction sets including traditional and electronic batch records and traditional and electronic work instructions. The group also leads the investigation of process deviations, root cause analysis and definition and implementation of CAPA. The organization ensures the maintenance of commercial operations to ensure on time delivery of high quality products that meet patient needs. Reporting directly to the APU Head, at Framingham Biologics, the position provides leadership and direction to the team of manufacturing specialist that manage product lifecycle change management processes and deviation investigations across the multiple value streams. The Associate Director will be responsible to recruit and develop a high performing team of qualified staff . The Role is responsible and accountable for maintaining the systems, system metrics and managing continuous improvement initiatives.Core Responsibilities:+ Responsible for recruiting, develop and managing the daily activities of a team of manufacturing specialists and subject mater experts + Responsible for developing appropriate queries and maintaining relevant performance metrics to ensure the health of manufacturing aspects of the quality management system Maintain tracking and trending tools to anticipate future needs + Responsible for developing key performance metrics (KPIs) and leading continuous improvement inanities + Develop systems and maintain processes for daily management of QMS priorities + Maintain Product Lifecyle Change Management including electronic batch records and electronic work instructions + Responsible for performing thought deviation investigations, identifying true root cause, and implementing effective corrective and preventative actions. + Responsible for managing the Periodic review + Provides comprehensive audit management and support for internal and external cGMP inspections + Responsible for managing a matrixed support team and providing the business partnership support for Autonomous production units for each value stream + Responsible for monitoring metrics to ensure progress towards performance goals, identifying and addressing systemic issues affecting execution, coordinating immediate responses to events. + Responsible for communicating performance to Site SLT, and additional key stakeholders.Leading People+ Sanofi leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organization. + Sanofi leaders are versatile learners who are comfortable with complexity and ambiguity. They are courageous decision makers who are candid and direct.Leading the Business+ Sanofi leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious, and create a compelling vision and direction that inspires engagement from their people. + Sanofi leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches. They have a track record of generating successful new ideas that improve business performance with a Play to Win mindset.Delivering to Customers+ Sanofi leaders understand the patient and customer viewpoint. They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good. + Sanofi leaders set ambitious and realistic targets, drive for results, and build accountability within the organization. They set high standards and continuously improve.Basic Qualifications:+ Bachelor's Degree with 10 or more years' of experience in pharmaceuticals or a related cGMP industry and 5 or more years' experience management experience + Able to work with and lead cross functional teams through complicated processes in a Quality system + Capable of effective and clear communication that enables teams to execute on key deliverables Experience coaching teams through regulatory inspectionsPreferred Qualifications:+ Bachelor's or Masters Degree in science, engineering, or other technical field + 2 or more years experience managing a manufacturing specialist or similar organization + Significant knowledge and experience with digitally integrated manufacturing systems (MES, PAS, MRP systems, etc.) + Technical experience in the operations and quality management systems of commercial biologics and/or vaccine production technologies. 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-SG /#LI-GZ 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.

Keywords: Sanofi Group, Framingham , Associate Director, Manufacturing Specialists, Other , Framingham, Massachusetts

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