Head of Quality Compliance

Job Title : Head of Quality Compliance Location: Framingham, MA About the Job The Quality Assurance Department is responsible for providing oversight on all GMP activities and related functions associated with the manufacture and release of biological products at the site.  The department manages the compliance program for the Framingham Biologics, Framingham Biosurgery and Northborough sites (e.g. Self Inspection, Dossier Compliance, External Inspections) and provides site metrics to determine site performance against Quality Metric Indicators. The department’s goal is to ensure that policies, procedures and processes are in place so that all site Quality Management System activities meet applicable regulations while allowing for monitoring the progress and the completion of Quality Compliance-related activities.   We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities Developing, implementing, and maintaining an effective compliance program ​ Ensuring that the Site complies with all laws, regulations, and standards applicable in the pharmaceutical industry Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters Maintaining a system to ensure compliance and quality risks are properly identified, tracked and mitigated Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance Ensure that any compliance issues are reported to the relevant authorities in a timely manner Manage and resolve any compliance issues, or allegations that arise and take appropriate corrective and preventive actions. Establishing and monitoring key performance indicators (KPIs) and metrics for the site compliance, and reporting on the results to management.​ Host the Business Owners self-inspection and other key systems Identify and drive continuous improvement initiatives and projects to enhance the site compliance fostering a culture of compliance Leading and managing the compliance team, including hiring, training, coaching, professional development and performance evaluation.​ Leadership Skills: An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. Being honest and treating people with respect and courtesy. Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. Sanofi’s leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers. Sanofi’s leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement. Delivering to Customers: Sanofi’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence. About You Basic Qualifications Bachelor’s degree in a science or equivalent with 10+ years of experience or Master’s degree with 8+ years’ experience working in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics). 8+ years’ experience managing people/projects or related experience influencing others Experience with hosting and managing regulatory inspections (PAI, General GMP, For-Cause inspections, etc.) Proficient in computer software programs and applications. Effective communication skills (listening, verbal and written). Ability to collaborate across functions and throughout all levels. Broad working knowledge of cGMP and pharmaceutical regulatory requirements (21-CFR Part 11, 210&211, 600,610); EU-GMP and EU Annex, ISO, ICH guidelines, PIC/s. In-depth knowledge of the systems-based inspection approach to regulatory inspections. Understanding of Aseptic processing, use of SUT as a manufacturing platform, use of digital systems in manufacturing operations. Special Working Conditions: Ability to gown and gain entry to controlled, classified areas Project Management skills and knowledge. Proven record in executing and delivering results. Equipment and process validation in cGMP environment. Knowledge of Total Quality Management (TQM), ISO, Six-Sigma, etc.  In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH). Leading and managing the compliance team, including hiring, training, coaching, professional development and performance evaluation.​ Proficient in computer software programs and applications. Effective comm