Sanofi Group Director QA Digital in Framingham, Massachusetts
This position resides within Quality Assurance (QA) and provides QA oversight of introduction of new Digital technologies/processes and complex change controls with validation and regulatory impact. This position includes oversight of the Digital Compliance department, to ensure compliant and efficient implementation and ongoing compliance of GxP digital solutions, including , but not limited to, development of comprehensive life cycle processes that interconnect digital compliance with control strategies, validation strategies, computerized systems, quality testing and release functions, review and approval of validation lifecycle documents, procedures, and technical reports related to data governance and digital compliance.
This position also champions and leads integration of Data Integrity/Governance principles and structure into QMS processes.
Lead/support implementation of digital-solution modernization of quality organization processes and procedures.
Work locally (site) and within network to identify digital ways of working to support lean manufacturing/operations. Responsibilities may include utilization support/help, training creation and delivery, validation support (quality compliance SME/approver), GxP/production support (quality compliance SME/approver) and network support.
Digital compliance provides leadership, direction, consultation, and oversight for the Framingham/Northnorough sites Data Integrity and CSV programs and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and Sanofi directives, standards and guidance.
Areas of focus include strategic direction & leadership for the DI Prgram (20%), strategic direction & leadership for the CSV progam (30%) and operationalization of complex Digital operations, and providing feedback and ensuring alignment with Global initiatives and standards.(30%) with the remaining focus on mentoring and developing staff as well as promoting continued DIgital maturity at the sites
POSITION OVERVIEW WITH KEY RESPONSIBILITIES
This position provides leadership, consultation and direction in support of complex GMP and technical challenges related to site DIgital initiatives and objectives.
This position serves as a consultant in current and long-range planning relative to new or projected areas of technological research and advancements and sets operating plans for areas of responsibility.
This position allocates resources to fulfill near term goals and commitments while building towards sustainable manufacturing excellence.
It is the responsibility of this position to motivate and lead his/her organization according to Sanofi policies to achieve business objectives that will have a major impact on the success of the Corporation.
Provides leadership, consultation and direction to Operations, Quality Control, and Quality Assurance on introduction of new Digital technologies/processes and complex change controls with validation and regulatory impact
Interfaces with Biologics Quality and leaders in the Sanofi network to identify and implement opportunities for simplification, harmonization and best practice sharing in Quality Assurance
Accountable for site level compliance of data integrity and CSV to Sanofi standards and to the requirements of US and international regulatory agencies
Utilizes SMS tools to drive continuous improvement in digital compliance department performance
Assures timely and technically appropriate oversight of GMP process to assure appropriate data governance .
Continuously increase awareness of regulatory and industry guidelines and practices to ensure site operations remained aligned with and improving toward “best in class” digital compliance.
Bachelor's Degree in a science or technical field
12 years of experience in pharmaceuticals or other highly regulated industry ( Biotech, Medical Device, Areospace, Chemical, Food or Automotive ) 5+ years in management position, inclusive of leading people leaders, or an equivalent combination of education and experience,
- Master's Degree with 8 years of experience in pharmaceuticals or another highly regulated industry, 5+ years in management position, inclusive of leading people leaders, or an equivalent combination of education and experience.
Operations experience in one or more of the following areas: Quality, Quality Control, IT, Manufactuirng, Validation.
IT relevant experience, including computer system validation and life cycle management of computer systems
Data Intergity program experience, establishing and improving the program, with demonstrated attention to lean approaches and program adoption throughout an organization.
Demonstrated ability to lead cross functional project teams to accomplish complex objectives on time and in budget
Demonstrated ability and experience with problem solving methodologies
Experience implementing digital technologies
Demonstrated ability to effectively manage all aspects of regulatory projects
Post Graduate Studies as appropriate to augment Primary Degree
SPECIAL WORKING CONDITIONS
Ability to gown and gain entry to controlled classified areas.
Ability to work remotely up to two days a week.
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.
- Sanofi Group Jobs