Sanofi
About the Job
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. 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 registrations are maintained. Ensure Swiftwater manufacturing operations operate in full compliance with applicable regulations and registrations to guarantee quality and safety prior to product release and throughout shelf-life.
Ensure that applicable requirements are included in development and technical transfers for effective industrialization, regulatory submission and timely approval. Represent the site as Quality head regarding product quality, safety and cGMP compliance.
Oversees the
QC activities
to guarantee that all products are tested and compliant with applicable standards and specifications. Manage QC testing operations to guarantee product availability for market release in a timely and cost-effective manner.
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 to senior management. Develop, maintain and control departmental budgets.
Provide guidance and technical support for project planning, process, systems and computer validation, aseptic processes and validation, component/product release, trending, investigations, product assessment, disposition, 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 objectives 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 policies.
Lead and manage the quality team
including hiring, training, coaching, development, and performance evaluation.
As a member of the SLT (Site Leadership Team) ensure leadership presence. Through the reporting line to Corporate Quality, align site programs with Corporate and Global functions.
Promote a
culture of quality
throughout the site organization. Foster continuous improvement, innovation, and the implementation of new technologies, tools, and methods.
Key Accountabilities
Ensure a fully compliant Quality System Management (QSM) is implemented at Swiftwater across manufacturing operations, in compliance with regulations and registration files.
Ensure products released meet cGMP requirements and registered specifications for quality, purity, potency, strength and safety.
Regularly assess the effective and compliant implementation of the QSM, monitor performance and cGMP compliance, report status to site and upper management, and define action plans when necessary.
Implement, drive and monitor a continuous improvement plan across the site and with suppliers/subcontractors regarding product/service quality, safety and cGMP compliance.
Define and execute strategy related to Quality and cGMP Compliance improvement for Swiftwater aligned with Corporate/Global strategies and goals.
Play an active role in defining and implementing 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 about 300 - 350 headcounts.
Key indicators for evaluation: Quality indicators, regulatory inspections.
Freedom to act, autonomy: authority to release or reject materials and manufactured batches; authorize or stop manufacturing based on GMP and regulatory evidence; review and approve quality documents and reports; push for decisions on cGMP and RA compliance.
About You Required Qualifications
Bachelor's Degree in Science required (Master’s/Doctorate preferred) with a minimum of 15 years’ experience in pharmaceutical or related industry focused on Quality Operations. Background in manufacturing, development, QA, QC, and Regulatory Affairs.
Competencies (LEAD model): 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 expertise with cGMP requirements including WHO, ICH, US FDA, Canadian BGTD, Australian TGA, EU GMP, Japanese authorities.
Strong technical expertise in Biotech manufacturing.
Ability to work strategically in a fast-paced environment and make balanced quality decisions.
Effective verbal and written communication across multiple organizational layers.
Experience interacting with regulatory agencies and health authority inspections.
Excellent organizational, interpersonal and leadership abilities.
Strong customer focus with ability to prioritize and adapt to business needs.
Diverse knowledge across business, quality, and industrial manufacturing.
Preferred Qualifications
Strategic direction for quality and compliance policies and systems.
Supply chain performance, testing, validation, computer systems, training, continuous improvement.
R2L support for development testing, design and support, transfer and commercialization.
Role includes developing and maintaining quality policies; leadership in global policy and strategy; reporting to VP, M&S Vaccines, US.
Quality position influences site executive decisions, global supply chain, and corporate policy; participates in Corporate Committees.
Ability to assess controls, compliance, quality and efficiency; define improvement initiatives; evaluate deviations; establish policy priorities.
Develop initiatives to improve compliance and quality.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Opportunities to grow your talent and career, including promotions or lateral moves, domestically or internationally.
Rewards package recognizing contribution and impact.
Health and wellbeing benefits including substantial 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 or domestic partnership status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, natural or protective hairstyles, marital or domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
North America Applicants Only
The salary range for this position is: $210,000.00 - $303,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link.
#J-18808-Ljbffr
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. 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 registrations are maintained. Ensure Swiftwater manufacturing operations operate in full compliance with applicable regulations and registrations to guarantee quality and safety prior to product release and throughout shelf-life.
Ensure that applicable requirements are included in development and technical transfers for effective industrialization, regulatory submission and timely approval. Represent the site as Quality head regarding product quality, safety and cGMP compliance.
Oversees the
QC activities
to guarantee that all products are tested and compliant with applicable standards and specifications. Manage QC testing operations to guarantee product availability for market release in a timely and cost-effective manner.
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 to senior management. Develop, maintain and control departmental budgets.
Provide guidance and technical support for project planning, process, systems and computer validation, aseptic processes and validation, component/product release, trending, investigations, product assessment, disposition, 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 objectives 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 policies.
Lead and manage the quality team
including hiring, training, coaching, development, and performance evaluation.
As a member of the SLT (Site Leadership Team) ensure leadership presence. Through the reporting line to Corporate Quality, align site programs with Corporate and Global functions.
Promote a
culture of quality
throughout the site organization. Foster continuous improvement, innovation, and the implementation of new technologies, tools, and methods.
Key Accountabilities
Ensure a fully compliant Quality System Management (QSM) is implemented at Swiftwater across manufacturing operations, in compliance with regulations and registration files.
Ensure products released meet cGMP requirements and registered specifications for quality, purity, potency, strength and safety.
Regularly assess the effective and compliant implementation of the QSM, monitor performance and cGMP compliance, report status to site and upper management, and define action plans when necessary.
Implement, drive and monitor a continuous improvement plan across the site and with suppliers/subcontractors regarding product/service quality, safety and cGMP compliance.
Define and execute strategy related to Quality and cGMP Compliance improvement for Swiftwater aligned with Corporate/Global strategies and goals.
Play an active role in defining and implementing 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 about 300 - 350 headcounts.
Key indicators for evaluation: Quality indicators, regulatory inspections.
Freedom to act, autonomy: authority to release or reject materials and manufactured batches; authorize or stop manufacturing based on GMP and regulatory evidence; review and approve quality documents and reports; push for decisions on cGMP and RA compliance.
About You Required Qualifications
Bachelor's Degree in Science required (Master’s/Doctorate preferred) with a minimum of 15 years’ experience in pharmaceutical or related industry focused on Quality Operations. Background in manufacturing, development, QA, QC, and Regulatory Affairs.
Competencies (LEAD model): 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 expertise with cGMP requirements including WHO, ICH, US FDA, Canadian BGTD, Australian TGA, EU GMP, Japanese authorities.
Strong technical expertise in Biotech manufacturing.
Ability to work strategically in a fast-paced environment and make balanced quality decisions.
Effective verbal and written communication across multiple organizational layers.
Experience interacting with regulatory agencies and health authority inspections.
Excellent organizational, interpersonal and leadership abilities.
Strong customer focus with ability to prioritize and adapt to business needs.
Diverse knowledge across business, quality, and industrial manufacturing.
Preferred Qualifications
Strategic direction for quality and compliance policies and systems.
Supply chain performance, testing, validation, computer systems, training, continuous improvement.
R2L support for development testing, design and support, transfer and commercialization.
Role includes developing and maintaining quality policies; leadership in global policy and strategy; reporting to VP, M&S Vaccines, US.
Quality position influences site executive decisions, global supply chain, and corporate policy; participates in Corporate Committees.
Ability to assess controls, compliance, quality and efficiency; define improvement initiatives; evaluate deviations; establish policy priorities.
Develop initiatives to improve compliance and quality.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Opportunities to grow your talent and career, including promotions or lateral moves, domestically or internationally.
Rewards package recognizing contribution and impact.
Health and wellbeing benefits including substantial 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 or domestic partnership status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, natural or protective hairstyles, marital or domestic partnership or civil union status, sex, gender, gender identity or expression, sexual orientation, disability, veteran or military status, or other protected characteristics.
North America Applicants Only
The salary range for this position is: $210,000.00 - $303,333.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link.
#J-18808-Ljbffr