Senior Manager, Manufacturing & QC

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  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.
  

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  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.
  

Job Scope

Guarantees efficient and effective production and packaging processes of components and finished products and control of raw materials, components and finished products for the LIAISON product lines of the Stillwater site in accordance with the production plans and in compliance with the requirements of Quality, managing the investigation activities in case of Non-Conformities and/or Complaints attributable to the functioning and packaging of the materials/products.

- Manages the team of coordinators of the Quality Control laboratories.

- Implements programs aimed at improving the control processes of the products of competence and collaborates in the management of the plant quality system, periodically reporting on the results and progress of the activities and promoting actions to improve the system in the area of competence.

- Collaborates with the Research and Development staff in the transfer of new projects within the company and with external bodies with a view to optimizing/introducing technologies and analytical methods. Supports the Analytical Methods Development team in the implementation of development projects.

Key Duties and Responsibilities

- Ensure the production and primary and secondary packaging of components/kits according to the plans agreed with Logistics;

- Ensure immunometric controls of raw materials, semi-finished products and finished products, ensuring the correct maintenance of the standards and necessary materials;

- Ensure the synchronization of activities between Production, Quality Control and Packaging, within the times agreed with Planning and in compliance with pre-established methods and procedures;

- Manage the Material Acceptance Quality Control activities within the QC & Manufacturing group in the Operations area.

- Ensure the correct coordination of the activities of the Microbiological QC, the Chemical-Biochemical QC and the Dimensional QC, ensuring the maintenance of the times and quality standards;

- Interact with the Warehouse, Planning and Procurement areas, in order to guarantee the correct execution of the activities aimed at guaranteeing the presence of approved and functional raw materials, necessary for the production of the diagnostic kit

- Coordinate the analytical methods development team in the validation and application of the principles required by current regulations.

- Is responsible for the optimization of resources and ensures their training, updating and development, with particular attention to safety, ecology, environmental hygiene and compliance with current regulations.

- Interact with QA in the technical evaluation of supplier change notifications, supporting the Change/OOS/NC/CAPA evaluation activities generated internally.

Evaluate and approve, for the part of his/her competence, the project documentation in which he/she is involved

- Define target objectives and verify the progress towards their achievement.

- Assign objectives to his/her collaborators

- Ensure, in collaboration with the "Post-Market Surveillance" body, the necessary studies, resulting from the assessments of the Competent Authorities;

- Develop and implement projects aimed at improving production and analytical processes as well as the performance of distributed products.

Education, Experience, and Qualifications

• Degree in technical-scientific subjects or equivalent

• At least 10 years of experience in related role in the pharmaceutical/biomedical field, preferably in the Medical Device sector
• Knows in depth the assay schemes used in the company and their diagnostic meaning. Knows the flows applied to the production and packaging departments.
• Chemistry, Biochemistry, Biology, in-depth knowledge of the Quality Management System and FDA regulations
• Ability to manage and coordinate work teams.
• Project management skills.
• Excellent analytical and planning skills.
• Leadership, strong orientation towards results and good stress management.

What we offer

Salary Range

The salary range for this position is $132,750 - $165,250 Annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.