Stevanato Group · 3 days ago
Site Leader of Quality
Fishers, IN
Full-time
Onsite
Director/Executive
10+ years expStevanato Group is seeking a Site Head of Quality for their Fishers, IN plant, which is starting up commercial production. The role ensures end-to-end oversight of quality processes and products, safeguarding compliance with quality management systems and regulatory requirements while driving a culture of excellence and integrity.
Health CareManufacturingPharmaceutical
Hiring Manager
Alisa Norris
Responsibilities
Lead, develop and oversee the quality management system execution at a site level with the aim of ensuring end-to-end compliance with the corporate SOPs, standards, regulatory and customer requirements
Act as Quality Representative at a site level, conducts regular quality management reviews, as well as participates in dealing with the third parts auditors, regulatory authorities, and other representatives in managing audits, inspection and customer site visits, to ensure the site will be compliance with requirements
Lead and oversees quality control processes execution such as material sampling, final product inspection, calibrations, testing, monitoring and ensuring the on-time delivery, prioritizing goals and targets, providing feedback to the relevant stakeholders
Maintains and supports deviations, change controls, documentation and oversees CAPA to achieve high level of quality, preventing, correcting and reducing quality issues
Ensuring that the Quality Control group meets and applies efficiently and effectively the QMS, customer specifications and requirements
Leads and oversees quality assurance processes including final batch release, change control, OOS, deviations, CAPA, documentation management, quality records, history controls, supplier monitoring and quality audit etc
Ensure the delivery of all activities related to quality assurance processes, leads key projects and initiatives aimed at improving the know-how, methods and team expertise as well as reducing the quality issues, maintaining high standards level
Provides the functions involved in the collaboration network with technical training, as well as ensuring application of Good Documentation Practices in all documents, guidelines, policy and procedures following QMS
Manage, coach and develop assigned staff, ensuring effective talent management in terms of training and career development
Lead the budget process for the function and properly manage the assigned budget
Interacts regularly and effectively communicates with the key internal leaders and teams as well as relevant stakeholders aimed at building level of awareness on quality vision and strategy fostering quality culture permeation in the whole organization
Qualification
Required
10+ years of experience within quality (quality assurance / quality control)
5+ years of experience managing a team
Bachelor's Degree
Experience working in a regulated environment (Food & Beverage or other regulated industries)
Strong flexible, adaptable, leader who does not fear ambiguity or grey area
Thrives working hands on with team members
Company
Stevanato Group
Founded in 1949, Stevanato Group is one of the world's largest providers of integrated containment and delivery solutions for the biopharmaceutical industry.
5001-10000 employees
H1B Sponsorship
Stevanato Group 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 (1)
2024 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$796.75MKey Investors
BNL BNP ParibasBiomedical Advanced Research and Development Authority (BARDA)
2025-07-23Post Ipo Debt· $234.61M
2024-03-21Post Ipo Equity· $330M
2023-03-08Post Ipo Debt· $137.14M
Recent News
2025-11-07
2025-11-07
2025-11-01
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