The IMA Group is a world leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceutical, cosmetic, food, tea and coffee products, as well as in the automation of industrial processes. We are constantly focused on innovation, through significant investment in R&D and constant dialogue with customers, the local community and the supply chain, we promote an environmentally friendly attitude with a view to achieving sustainable development. Our history is one of steady growth, also achieved through continuous investment in the development of people and their skills. We have over 7,000 employees, 59% in Italy and 41% in the rest of the world, present in more than 80 countries.
IMA Life North America is a division of the IMA Group specializing in aseptic processing and freeze-drying solutions for the pharmaceutical and biotech industries.
It is part of the IMA Life, which focuses on the pharmaceutical sector and providesadvanced technologies for filling, lyophilization, and isolation - ensuring maximum sterility and product integrity for customers around the globe. We are looking for a Quality Manager for our site in Tonawanda, NY.
JOB SUMMARY
The Quality Manager will be responsible for ensuring the effectiveness of the Quality Management System, promoting a culture of continuous improvement, and supporting strategic initiatives across the organization. This position plays a key role in aligning quality systems with customer expectations and regulatory requirements, while also fostering a collaborative and high-performance work environment.
Key responsibilities include:
- Provide quality leadership and drive continuous improvement initiatives by managing a team of Quality Assurance and Quality Control personnel.
- Ensure QMS (Quality Management System) compliance and maintain certifications and regulatory accreditations.
- Support the implementation of SHEQ (Safety, Health, Environment and Quality) systems to promote a safe working environment, in collaboration with the Environment, Health and Safety Manager.
- Lead Six Sigma change management initiatives to reduce process variation and improve performance.
- Support New Product Introduction (NPI), change control, and validation activities.
- Collaborate with corporate peers and ensure process and documentation standardization across projects.
- Plan departmental resources and budget; monitor project and strategic initiative progress.
- Implement continuous process and procedure improvements; define and maintain best practices.
- Manage internal and external audits, supplier relationships, and team performance evaluations.
- Oversee quality control processes, ensure product quality standards, and analyze cost of poor-quality metrics with corrective/preventive action plans.
MUST HAVE
- Bachelor's Degree in a technical or science-related field.
- Experience in cost of poor-quality analysis and corrective/preventive action implementation.
- Minimum 5 years of experience in management, quality, technical, or operations-related roles.
- Lean Six Sigma Black Belt certification strongly preferred; candidates with equivalent experience in process improvement are encouraged to apply.
- Experience in capital equipment manufacturing or comparable regulated industrial environments.
- ISO9000 Lead Assessor certification.
- Strong knowledge of SPC, process controls, and quality tools.
- Working knowledge of GAMP, and cGMP.
- Ability to lead teams, communicate information clearly in written or verbal form, and maintain professional working relationships in accordance with job duties.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Project, Access).
- Ability to work effectively in collaborative environments.
- Familiarity with Non-Conformance Report (NCR) and Verification Conformance Request (VCR) systems.
NICE TO HAVE
- Analytical troubleshooting skills.
- Experience managing external quality suppliers and outsourced manufacturing services.
- Auditor training experience.
IMA LIFE IS AN EQUAL OPPORTUNITY EMPLOYER