Head of Site Quality Operations

Sanofi•Swiftwater, PA

64d•Onsite

About The Position

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?

Requirements

Bachelor's Degree in Science required (Master's/Doctorate in Science preferred) with a minimum of 15 years experience in pharmaceutical or related industry with a concentration in Quality Operations. Background in manufacturing and development, Quality Assurance, Quality Control, and Regulatory Affairs.
Deep and practical expertise with cGMP requirements including WHO, ICH, US FDA, Canadian BGTD, Australian TGA, EU GMP, Japanese… ; but are not limited to the named Health Authorities and organizations.
Strong technical expertise in Biotech manufacturing.
Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization.
Experience interacting with regulatory agencies and health authority inspections is required.
Excellent organizational, interpersonal and leadership/teamwork abilities are required.
A strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required.
Diverse business, quality, and industrial manufacturing knowledge base.

Nice To Haves

Overall strategic direction and guidance of the company's quality and compliance policies and systems
Supply chain performance, related testing, validation, computer systems, quality systems, training, product assessment, continuous improvement
R2L support in terms of Development testing, design and support, technical transfer and commercialization
This includes developing and maintaining quality policies throughout Sanofi. These quality policies include establishing and monitoring effective compliance programs in the cGMP 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 policy, direction and strategy. This position maintains reporting to the VP, M&S Vaccines, US.
Quality position influences site executive management's decisions, global supply chain, and corporate policy. As a member of Corporate Committees, influences corporate decisions.
To access the state of controls, compliance, quality and efficiency on a constant basis and to facilitate improvement
To design, provide, evaluate improvement initiatives for implementation in strategic plans.
To determine the significance of deviations in a process, component or systems.
To define policies and approach to strategic and tactical issues (e.g. validation master plan)
To define quality systems adequate to sustain quality and compliance
To establish departmental priorities and resource allocation.
To develop any initiative to improve compliance and quality

Responsibilities

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, training, coaching, professional development, and performance evaluation.
As a member of the SLT (Site Leadership Team) ensure appropriate leadership and management presence. Through the functional reporting line to Corporate Quality, ensure alignment of site programs and objectives with the Corporate (Sanofi) and Global (Sanofi) functions.
Promote a culture of quality throughout the site organization. Foster continuous improvement and economical performance, innovation, and the implementation of new technologies, tools, and methods.

Benefits

Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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