Quality Assurance Project Lead South Cluster

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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.

Applies 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).

Conducts risk assessments on QMS processes to identify and mitigate any risks.

Supports with process validation on new processes and new Buildings.

Support and complete Design Qualification in a new Building and/or with new Clients.

Keeps track of the projects, monitors the progress and identifies best practice and lessons learned.

Coordinates 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
Internal

Project Management

Operations Management

QA Department / Document Control Department

Solutions / Implementations

Security

BaSe Team

Procurement Department

Validation Department

IT/ FUR Department

External

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