QA Leader Italy

**Job Description Summary**: Develop and maintain systems, rules, and processes to ensure fulfilment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards.

In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

The Quality Assurance Manager PDX Italy is responsible to ensure continued compliance at external sites to GE Healthcare’s quality requirements and applicable regulatory standards. Definition of quality objectives, metrics and reporting and operating mechanisms

**Key responsibilities include**:

- Accountable for ensuring full quality and regulatory compliance to GE Healthcare and regulatory expectations.
- Acting as Responsible Person ensures that activities carried out by GE Healthcare Srl complies with current GMP/GDP according to Company policies on Marketing, Storage and Distribution of medicinal products and medical devices.
- Ensures audit readiness and conduct the Quality System audits; prepares and executes Quality Management System reviews.
- Maintains positive agency relationships-liaisons with regulatory agencies upon inspections and participates in external technical forums.
- Owns compliance assessment and remediation plans functional policy, development programs, and communications and training requirements for Quality matters.

**Quality Specific Goals**:

- Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required
- Meet GE Healthcare QMS procedure deployment plan dates Assure specific quality goals are established and met for compliance, training, CAPA, complaints and production process controls.

**Qualifications**:

- Pharmaceutical degree preferably or Chemistry, Biology degree required.
- Minimum 5 years Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry
- Minimum 1 year supervisory/management experience
- Proficient in MS office. prior experience using word processing, spreadsheet, and presentation software
- Demonstrated experience with regulations in the pharmaceutical industries
- Ability to communicate using English and Italian

**Preferred Qualifications**:

- Proven managerial/leadership skills such as work planning, delegating & evaluating.
- Demonstrated knowledge of Quality Management System tools &, continuous improvement.
- Demonstrated expertise to effectively communicate within all levels of the organization.
- Demonstrated collaboration, negotiation & conflict resolution skills.
- Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
- Demonstrated effective interpersonal, teamwork & networking skills.
- Exceptional analytical, problem solving & root-cause analysis skills.
- Ability to make decisions, even when under pressure & take ownership for assigned projects and programs.
- Ability to multi-task & handle tasks with competing priorities effectively
- Integrity: Accepting & adhering to high ethical, moral & personal values in decisions.

**Inclusion and Diversity**

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

**Behaviors**

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

**Total Rewards**

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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**Additional Information**:
**Relocation Assistance Provided**:No