Chiesi USA, Inc. · 1 day ago
Head of Quality Process
Dublin, IN
Full-time
Hybrid
Director/Executive
15+ years expChiesi USA, Inc. is an international pharmaceutical and healthcare group focused on improving quality of life. They are seeking a Global Quality Process Head to design and implement a compliant Quality Management System across global operations, ensuring alignment with regulatory standards and fostering a culture of continuous improvement.
BiotechnologyMedicalPharmaceutical
Responsibilities
Develop and lead the global QMS strategy, ensuring alignment with business goals and regulatory expectations
Establish governance frameworks for quality systems oversight
Ensure QMS compliance with global regulatory standards
Oversee core QMS processes: CAPA, Change Control, Deviations, Document Management & Training
Drive harmonization and simplification of quality processes across sites and functions
Support the implementation and optimization of electronic QMS platforms (e.g., Veeva Vault QMS and QDocs)
Lead global training needs for the global quality organisation
Lead and develop a global team of quality systems professionals
Collaborate cross functionally with stakeholders reg affairs, IT, operations, engineering
Lead collaboration forums for QMS quality systems across the network globally with the local quality system process owners to drive best practices and continuous improvements
Qualification
Required
Bachelor's degree in Pharmacy, Life Sciences, Engineering, or related field (Master's or PhD preferred)
Minimum 15 years of experience in pharmaceutical quality systems, with at least 5 years in a global leadership role
Deep understanding of global pharmaceutical regulations and GxP requirements
Proven experience in leading QMS transformations and digital implementations
Strong leadership, communication, and stakeholder engagement skills
Preferred
Experience with regulatory inspections (FDA, EMA, PMDA, etc.)
Expertise in clinical & commercial GMP/GDP quality systems
Experience working and leading in a global matrixed work environment an advantage
Benefits
Continuous training, learning and development
Quality of our working environment
Collective well-being
Flexible working approach
Remote working
Support in the relocation process
Tax assistance service for foreign colleagues
Many other people-care services
Company
Chiesi USA, Inc.
Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services.
201-500 employees
H1B Sponsorship
Chiesi USA, Inc. 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 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$0MKey Investors
North Carolina Biotechnology Center
2020-08-04Grant· $0M
Leadership Team
Jon Zwinski
Chief Executive Officer - General Manager
Molly Rice
Senior Human Resources Business Partner / Associate Director Human Resources
Recent News
Clinical Trials Arena
2024-05-24
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