Plans and coordinates operations to meet production schedules, product standards, and operational costs.
Prepares production, personnel and financial reports to achieve production goals. Establishes operating policies and procedures to achieve production schedules, product standards, and operational costs.
Responsible for the coordination of multiple functions within a facility.
Manages the commercial scale cGMP, clean room manufacturing of Biosurgery products.
Production scheduling, meet demands of internal customers, and work with a cross functional team to meet product release cycle time.
Participates in the short and long range planning and budgeting process.
Ensures timely resolution of deviations related to production batches, and the on time implementation of corrective and preventative actions (CAPA).
Routinely work within a team including Manufacturing, Engineering, Stability, Validation, QA, QC, Materials and Regulatory to implement process, documentation, and equipment improvements.
Motivates and drives direct reports and support groups to meet key performance indicators (KPI) for site goals, including on time training, first pass yield, deviation per FTE, production yield targets, CAPA on time completion and cost of goods (COGM).
Manages for Daily Improvement-Engage the staff in continuous improvement efforts by managing effective daily MDI meetings.
Manages change control process to implement new equipment and process improvements.
Ensures the implementation and maintenance of Quality systems and policies.
Serves as a lead Manufacturing contact during audit and general support during audits by external regulatory agencies.
Oversees the CAPA program for the department, including review and approval of CAPA plans and implementations.
Reviews all related deviations and change controls.
Manages product risk profiles as they are impacted through change control.
Provides oversight and coordination for other ancillary compliance activities and programs such as facility shutdowns, sanitization, pest controls and walk-throughs.
Compiles and reports on internal compliance metrics during Management Review and other forums.
Ensures that documentation and operations meet established requirements of cGMPs, internal SOPs and corporate standards.
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.