Corporate QA Head Immuno Division

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

Lead, establish, implement and maintain quality assurance systems and activities. Ensure compliance with the applicable procedures, quality system standards and regulations for the diagnostic medical devices designed, produced and marketed by the company. Partner with Industrial Operations, Product Development, Quality Control, and others across functions to deliver the highest quality products. 

Interact and cooperate with the Corporate Quality Assurance team to ensure implementation of corporate compliance strategies.

Key Duties and Responsibilities

• Ensure that the quality management system demonstrates regulatory compliance per applicable standards and regulations at the Immuno Division level for all the Quality aspects and activities related to the Industrial Sites located in Italy, Germany,  UK and Stillwater
• Be the reference for all the Quality projects and activities related to the Immuno Division , interacting with the Industrial Operations
• Assure the adequacy and updating of the company's Quality System with respect to the mandatory regulatory requirements
• Disseminates knowledge of the Quality System at all Immuno Divisionlevels
• Assure, in collaboration with Quality Heads for Immuno Division at sites level the respect of compliance with the existing procedures
• Provides support and directions in surveillance of qualified suppliers by monitoring their performance and updating Senior Top Management on the ability of suppliers to meet the needs of the Company
• Assure by the Surveillance process the compliance and handling of non-compliant products. Oversees recall management. Includes tracking and closure. Oversees FSCA and FCA deployment and management
• Respond to alleged QMS violations of regulations, policies, procedures as the result of both external and external audits by evaluating and recommending the initiation of investigative activities, immediate corrections and risk analysis processes. 
• Ensure the IVD products are designed, produced and distributed in compliance with the existing quality and regulatory requirements
• Maintain contact with FDA,Notified Body for CE marking and other main HAs WW and releasing lots on the market
• Participate and manage activities for external audits such as ISO, FDA or other regulatory bodies for all Immuno sites. Coordinates responses to external audits and manages corrective actions to close
• Develop and release Quality Plans and actions to support the changing needs and requirements of the organization as the result of strategic changes in business direction
• Interact with various internal and external groups to facilitate the completion of internal audits, handling of non-conformances, performing Risk Assessments, CAPA, investigation and support, Design validation as well as Design Transfer
• Other duties as assigned

Education, Experience, and Qualifications 

Degree in scientific disciplines; Thorough knowledge of standards and regulations (cGMP, ISO 13485)

Minimum of 7 years experience at senior level in an international context in quality management systems relating to in vitro diagnostic medical devices;

Fluent knowledge of the English language

Extensive familiarity with quality assurance processes and procedures, and devise methods to enforce quality standards

Effective team leadership to assurance personnel management and direct activities

Possess strong written and verbal communication skills in order to communicate across departments and with the senior management

Effective problem-solving ability to assess quality issues and develop functional solutions

Ability to identify opportunities to improve departmental processes and procedures to increase efficiency and effectiveness

Strong understanding of corrective Action Process, and their application in manufacturing as a problem identification and resolution tool.

FDA Process Validation Techniques preferred

Good interpersonal skills, professionalism

Ability to work with cross functional teams

Ability to define problems, collect data, establish facts, and draw valid conclusions.

Ability to interpret an extensive variety of technical instructions

Ability to read, analyze and interpret technical procedures, or governmental regulations

Business Travels availability in EU and US

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.