Sanofi · 1 day ago
Head of Site Quality Operations
Swiftwater, PA
Full-time
Onsite
Director/Executive
15+ years expSanofi is a global healthcare company that has been a leader in the vaccine industry for over a century. The Head of Site Quality Operations is responsible for ensuring quality and regulatory compliance of products manufactured at the Swiftwater site, providing leadership in quality policies, and overseeing the quality management system.
Health CareLife SciencePharmaceuticalTherapeutics
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
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
Qualification
Required
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
Preferred
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
Quality position influences site executive management's decisions, global supply chain, and corporate policy
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.98BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.72B
2025-03-05Post Ipo Debt· $1.62B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-02-06
Company data provided by crunchbase