Head of Site Quality Operations

Job Title: Head of Site Quality Operations

Location: Swiftwater, PA

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.

Sanofi has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site for the production of several vaccines (150 million doses produced each year) which are distributed throughout the world.

This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site in accordance with Regulatory requirements and Global Quality policies and standards. This includes providing Quality leadership across the site organization as well as developing and maintaining quality policies throughout Sanofi. These quality policies include establishing and monitoring effective compliance programs in the GMP areas as well as other quality and compliance programs influencing the business and strategic operations.

The position is also a key leader in Sanofi Global Quality and Strategy. This position maintains reporting line to the VP, M&S Vaccines, US.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

• Ensure that all site activities are conducted in compliance with applicable regulatory requirements and that valid manufacturing licenses and marketing authorizations are maintained. Ensure that the Swiftwater manufacturing operations operate in full compliance with the applicable regulations and registrations in a sustainable and consistent way for guaranteeing that manufactured products are of the appropriate quality and safety prior to the product release and throughout shelf-life.
• Ensure that applicable requirements are included in development and technical transfers for an effective and efficient industrialization, regulatory submission and timely approval. Represent the site towards the concerned health authorities as the Quality head of the site with regards to product quality, safety and cGMP compliance as well.
• Oversees the QC activities to guarantee that all products are tested and compliant with applicable standards and specifications. Manage the QC testing operations in an efficient and compliant manner to guarantee product availability for market release in a timely manner and cost-effective way.
• Lead the SQC to provide direction and guidance to sustain quality and compliance. As head of Quality Department, raise compliance and quality issues and solutions/ proposals to senior management. Develop, maintain and control departmental capital and operating expense budgets.
• Provide guidance and technical support to the company for project planning, process, systems and computer validation, aseptic processes and validation, component/ product release, trending, problem investigations, product assessment, disposition, complaint management, records retention, document distribution & audit.
• Lead the site’s quality management system to ensure continuous compliance and certification. Ensure the implementation and maintenance of robust quality systems, in line with global quality.
• Develop and oversee the implementation of site quality roadmap in line with site CBN and global quality objectives and strategy.
• Support and provide guidance to Protein Sciences, NY site Quality team as needed.
• As the head of Quality, manage budget, supervise staff in accordance with Company commitment and appropriate policies and procedures. Lead and manage the quality team including hiring,…