Head of Site Quality Operations

Job Title: Head of Site Quality Operations

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. 

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?   

Main 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.

Key Accountabilities:

• To ensure that a fully compliant Quality System Management (QSM) is implemented at Swiftwater  across the manufacturing operations for ensuring that the site operates in a consistent way, in compliance with the applicable regulations and registration files.

• To ensure that the products released strictly meet the requirements in both cGMP compliance of the manufacturing, testing, storage and distribution operations and registered specification for quality, purity, potency, strength and safety.

• To assess regularly the effective and compliant implementation of the QSM across the industrial operations at Swiftwater, to monitor performance and cGMP compliance, to report status to site and upper management and to define and execute action plans when necessary.

• To implement, drive and monitor a continuous improvement plan across the site at Swiftwater and with suppliers and subcontractors with regards to product/service quality, product safety and cGMP compliance.

• To define and execute the strategy related to Quality and cGMP Compliance improvement for Swiftwater aligned with the Corporate/Global strategies and goals.

• To play an active key role in the definition and implementation of site objectives as a SLT member.

Scope & Dimensions:

• The function covers the entire scope of cGMP activities within Swiftwater Manufacturing & Supply.

• Key dimensions: Headcount (direct and indirect), budget, product release, quality systems, etc.

• The Site Quality Organization equals to about 300 - 350 headcounts.

• Key indicators on which the job holder will be evaluated (WHAT in 9box): Quality indicators, regulatory inspections.

• Freedom to act, level of autonomy:
  • Whilst remaining aligned with the site goals and strategy, keeping a teamwork approach and base on facts and evidences, the job holder has the authority:
  • To release or reject any of the materials, components and manufactured batches according to the relevant GMP and registered specifications and cGMP requirements.
  • To authorize or stop any of the manufacturing activity based on evidences of GMP and Regulatory compliance.
  • To define mandatory requirements to be included in cGMP projects related to any of the cGMP environment facilities, utilities, equipment, process, methods and products.
  • To review and approve all quality documents prior to their respective effective date and to review and approve all of the quality reports prior to their respective close-out.
  • To push for decisions and actions with regards to cGMP and RA compliance for the cGMP areas of the manufacturing operations of Swiftwater.

About You

Required Qualifications:

Specific degree, duration of experience (Required to hold the job):

• 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.

• Competencies (LEAD model) – key competencies the job holder will be evaluated on (HOW in 9box):  This position is measured on all 8 competencies, Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically, Commit to Customers, Develop People, Make Decisions, Lead Teams.

Key technical competencies and soft skills:

• 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.

Preferred Qualifications:

• 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

Why Choose Us?

• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

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