Chiesi USA, Inc. · 1 day ago
Head of Governance & Predictive Quality
Dublin, IN
Full-time
Hybrid
Director/Executive
15+ years expChiesi USA, Inc. is an international research-focused pharmaceutical and healthcare group committed to improving quality of life through innovative drugs. The Global Head of Quality Governance & Predictive Quality will lead the global quality governance framework, ensuring effective quality planning and fostering a proactive quality culture across the organization.
BiotechnologyMedicalPharmaceutical
Responsibilities
Own and lead the global quality governance structures, including the Quality Plan and tiered Quality Council framework
Act as Process Owner for the escalation and recall processes, ensuring timely and effective resolution of quality issues
Lead the Tier 3 Global Quality Council, driving strategic alignment and decision-making across the network
Harmonize KPI data across Chiesi GxP operations, lead KPIs development from Phase III through to commercial affiliates
Develop and implement predictive KPI analytics to proactively identify trends, risks, and opportunities for improvement
Support and optimize electronic platforms for quality governance and data management
Collaborate with local quality system process owners to drive best practices, continuous improvement, and global alignment
Ensure integration of governance processes with broader QMS and business objectives
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 significant experience in governance and data analytics
Proven leadership in global quality governance, KPI management, and cross-functional collaboration
Deep understanding of GMP/GDP regulations and quality risk management principles
Preferred
Experience with regulatory inspections and global compliance frameworks
Expertise in predictive analytics, digital quality platforms, and data visualization tools
Strong stakeholder engagement and communication skills
Experience working and leading in a global, matrixed organization
Benefits
Continuous training, learning and development
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
Company data provided by crunchbase