Quality Assurance Project Lead South Cluster

501 PIEFFE DEPOSITI SRL (SCS ITALY; Lodi, Milano; On-site; EUR 65,000 - 90,000; Full time

Job summary

UPS is seeking a Healthcare Quality Assurance Project Lead to coordinate and oversee the Quality Management System across healthcare projects. The role ensures ISO 9001 and ISO 13485 compliance, EU GMP and GDP alignment, and robust project delivery with internal and external partners.

Responsibilities include risk assessments, process validation support, design qualification, audits, and training development.

Qualifications

• Bachelor's degree or international equivalent in sciences.
• Quality Assurance experience preferred.
• Experience with ISO 9001 and ISO 13485 standards is required.
• Experience with GMP and GDP guidelines is an advantage.
• Root cause analysis tools (5 whys, FMEA) is a must.
• Ability to manage multiple projects and cross-functional teams.

Responsibilities

• Coordinate and maintain QMS in line with ISO 9001 and ISO 13485, and EU GMP and GDP standards.
• Assess and support projects from quality and compliance perspectives.
• Lead QA activities across building setups, client implementations, and equipment/process validations.
• Conduct risk assessments on QMS processes and implement mitigations.
• Support design qualification and process validation for new buildings and clients.
• Track project progress and share best practices and lessons learned.

Skills

English proficiency

Italian proficiency

Spanish knowledge

Strong communication

Organization & planning

Flexible hours

Education

Bachelor's degree in Sciences

Tools

MS Office

Job description

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Job Description: Location: Somaglia (Lodi) (on site, with flexibility) Contract: permanent Working hours: standard

The Healthcare Quality Assurance Project Lead South Cluster is responsible for coordinating and supporting quality assurance activities across healthcare projects, ensuring the effective implementation and maintenance of the Quality Management System in compliance with ISO 9001, ISO 13485, EU GMP, and EU GDP requirements. The role provides quality and compliance oversight for new buildings, client implementations, equipment, processes, audits, validations, risk assessments, change controls, and process improvement initiatives, while collaborating closely with internal stakeholders and external partners to ensure robust, compliant, and efficient project delivery.

RESPONSIBILITIES:

• Coordinate the implementation and the maintenance of the Quality Management System (QMS) in accordance with ISO: 9001 and ISO: 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.
• Apply his/her knowledge, skills and tools in assessing and supporting Projects from the quality and compliance point of view.
• Coordinate/execute various projects such as: Setting up the QMS in a new Building, Assessment of new Client opportunities, Implementation of new Clients, Implementation of new Equipment, Implementation of new Processes, Supports External Audits within the scope of Project Management (e.g. new Client Audits, initial Regulatory Inspection).
• Conduct risk assessments on QMS processes to identify and mitigate any risks.
• Support with process validation on new processes and new Buildings.
• Support and complete Design Qualification in a new Building and/or with new Clients.
• Keep track of the projects, monitor the progress and identify best practice and lessons learned.
• Coordinate process improvements projects within the applicable departments.
• Create and provide training related to Client implementation.
• Create Change Controls for any Projects where applicable.

KEY INTERACTIONS

• Project Management
• Operations Management
• QA Department / Document Control Department
• Solutions / Implementations
• Security BaSe Team
• Procurement Department
• Validation Department
• IT/ FUR Department
• Regulatory Agencies
• Clients
• Suppliers
• Third Party Auditors

QUALIFICATIONS

• Education level Bachelor's degree or International equivalent in Sciences- Required
• Pharmaceutical, healthcare or food industry experience - Preferred
• Quality Assurance experience - Preferred
• Specialized Knowledge
• Proven experience in managing ISO: 9001 and/or ISO: 13485 standards
• Proven experience with GMP and/ or GDP guidelines is an advantage.
• Experience with Supply Chain Industry is an advantage.
• Experience with Root Cause Analysis tools (e.g. 5 why’s, FMEA) is a must.
• Experience with Project Management is a must.

SKILLS

• Proficient in written and verbal English.
• Proficient in written and verbal Italian.
• Knowledge of Spanish is a plus.
• Strong verbal and written communication skills, to present recommendations and report back to different levels within the organization.
• Preferably experience in technical writing of documentation.
• Proficiency in Microsoft Office (MS Word, Power Point, and Excel).
• Knowledge of electronic Quality Management System is an advantage.
• Ability to prioritize decisions which may have a significant risk for the company.
• Ability to create networks and collaborate with various internal and external teams.
• Identify potential gaps in the processes and make recommendations for possible improvements.
• Coordination of improvement projects where needed.
• Implementation of new processes having a quality critical impact on the business.
• Recommend training opportunities.
• Strong organization, time management and planning skills.
• Flexible in working hours.

Employee Type: Permanent

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