Sanofi Group Director Quality Assurance in Framingham, Massachusetts
Sanofi’s R&D Genomic Medicine Unit (GMU) CMC group is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors, and cell therapy products. The R&D Site Quality Operations team supports the delivery of these products to our patients. The primary accountability of this role is to execute Sanofi’s cell and gene therapy manufacturing strategy and be responsible to support the cell therapy clinical manufacturing suite in Framingham, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.
Director Quality Assurance
Who You Are:
The Director of GMU Quality Assurance is tasked with providing strategic leadership, direction, and oversight of the Framingham Genomics Medicine Unit quality assurance organization and for assuring inspection readiness in alignment with CGMP, regulatory compliance requirements, and current industry guidance for clinical manufacture. The Director of QA is responsible for managing all QA functions and working with cross-departmental leadership to deliver high quality products on schedule.
Support the manufacture, testing and release of APIs and Drug Products managed by the Framingham GMU team
Oversee GMP compliance for clinical manufacture and testing, including release and/or rejection of API and Drug Product
Defines and implements the strategy to establish Quality within R&D support functions
Directs the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies.
Establishes operation policies that affect multiple organizational units.
Interprets, executes, and recommends modifications to organizational policies.
Oversees auditing schedules, materials, equipment, and manpower requirements.
Works on complex problems related to the compliance process and schedule for new or existing products requiring an in-depth analysis or various factors.
Formulates and recommends Quality policies and programs.
Responsible for all products/projects assigned to organizational units.
Provides guidance and advice to managers and supervisors to achieve goals related to validation/auditing schedules, processes, and methods.
Escalate unusual observations, deviations, or any incidence of non-compliance with established protocols or procedures.
Represent the department on specialized project teams; ensure the department is included in decision-making and resolution of critical issues.
In collaboration with the Site Head of Quality, participate in strategic planning and development activities including compliance, capacity, timelines and corporate direction.
Align department objectives with SQO and Biologics Development objectives.
Collaborate with senior leadership team in meeting corporate and organizational objectives.
Establish and report applicable department or organizational metrics.
Represent department in project team meetings related to global and R&D initiatives.
Interact with project teams and cross functional groups.
Interface with internal compliance and external regulatory agencies as required.
Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
Provide leadership, guidance, and direction to staff consistent with GMP and company corporate quality governance.
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards, and disciplinary action.
Develop work plans, assign tasks, and supervise team(s).
Manage staffing requirements based on projects.
Ensure staff has appropriate knowledge of department processes and procedures.
Provide organizational and managerial structure that supports the various levels in the organization.
Provide input into the department/cost center budget as required.
Manage headcount, project allocation and department spending in accordance with budget.
Bachelor’s degree in science or technical field and 10 years of experience in Biotechnology or compliance role within a CGMP environment.
8 years in Management
Comprehensive knowledge of FDA and EMA CGMP regulations and guidance
Experience in Cell or Gene Therapy Manufacture or Quality Control
Background in microbiology or aseptic processing
Application of GMP within early clinical manufacture setting
Knowledge of process transfer
Qualification/Validation requirements for biological products
Quality System management
THE FINE PRINT:
English, excellent written and spoken communication skills, general computer proficiency and understanding of same, and good organizational and interpersonal skills. The candidate is expected to develop and maintain the required technical knowledge and skills to operate in a highly regulated environment (i.e., CGMP). Position requires up to 15% travel, both domestic and international. Associated travel in this position includes audit/inspection of 3rd party suppliers and contract facilities, person-in-plant activities, and attendance at off-site training and seminars. Ability to gown and enter controlled manufacture areas.
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.