EM and S Vaccines and Large Molecules GenMed Head of Transversal Quality

EM and S Vaccines and Large Molecules GenMed Head of Transversal Quality

Location: Cambridge, MA, Framingham, MA, Morristown, NJ

About the Job

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.

External Manufacturing & Supply Vaccines and Large Molecule GenMed is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing of Sanofi products. EM&S Vaccines & LM GenMed staff interacts with functional units within other Sanofi sites, and other organizations within the External Manufacturing and Supply network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

EM&S Vaccines & LM GenMed has responsibility for CMO and CLO related to Vaccines and Large Molecule GenMed products in the associated Business Units.

The EM&S Vaccines & LM GenMed Head of Transversal Quality oversees the performance of GxP systems and procedures used by all functional units within EM&S Vaccines & LM GenMed. This individual provides strategic leadership, direction, and oversight for compliance and risk management programs and is responsible for fostering a culture of quality and continuous improvement.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.​

Main Responsibilities

• Ensure that area of responsibility is staffed, organized, and resourced to fulfill compliance obligations; provide leadership, guidance, and direction to staff consistent with GxP and company quality governance.

• Coach and mentor staff in all aspects of their job performance and career development including training, goals setting, feedback, rewards, and disciplinary action.

• Collaborate with senior management, peers, and team to routinely review/update the Site Quality Plan and ensure priorities are aligned with site and company business objectives.

• Be knowledgeable of products, CMOs, and distribution activities where they have responsibilities and be able to contribute towards technical reviews and make recommendations that improve the quality of the product and distribution activities.

•  Ensures procedures are consistent with all applicable corporate quality policies, standards and applicable GMP and GDP regulatory requirements.

•  Monitor performance of the QMS and ensure that systems and processes are controlled and/or validated per company and GxP requirements.

•  Supports complaints management, CAPA, and Deviation / Investigation systems; Quality Maturity Index (QMI) and global standard alignment / remediation programs; Quality Documentation system and records management; and coordination of the site Quality Management Review. Act as sponsor of the Site Supplier Management Team (SMT) and ensure all suppliers are on-boarded, monitored, and routinely re-assessed to ensure the Approved Supplier List is current and accurate.

•  Establish and report applicable department or organizational metrics; monitor compliance alignment versus other Sanofi network sites / organizations.

•  Ensure a Risk Management Program is in place to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involve a multi-disciplinary team to define remediation plans to risks impacting products and GxP operations.

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