Site Leader of Quality

Job Description

In partnership with Harba Solutions, Stevanato Group is hiring a Site Head of Quality for our Fishers, IN plant! We are starting up the commercial production in this USA plant and seeking a strong leader who does not stray from challenges.

As the Site Head of Quality, the position ensures end-to-end oversight of quality for both processes and products at the assigned site. This role safeguards full compliance with the Quality Management System (QMS), Corporate SOPs, applicable procedures, regulatory requirements, customer specifications, regulations, and industry standards. The role is the final authority for batch release, accountable for certifying that all site batches meet defined quality criteria before market distribution. Through cross-functional collaboration, and continuous improvement, they drive a culture of excellence, integrity, and compliance across all operational layers.

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.

Requirements :

Please apply to this posting for consideration or email Alisa Norris

alisa.norris.ext@stevanatogroup.com