Quality Assurance Leader

**Job Description Summary**: In this role you are the Responsible Person for the import, export and wholesale distribution activities of GE Healthcare AG, Switzerland under its Swissmedic licence. You will become the designated Fachtechnisch verantwortliche Person (FvP) for our Swiss Pharmaceutical Diagnostics business.

This role is hybrid based in Switzerland. The majority of the time you will work remotely with a regular visit to our Swiss warehouse and distribution center 40kms from Zurich.

At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.

**Your responsibilities**:
As FvP for GE Healthcare AG in Switzerland, you will be responsible for:

- The Quality Management System - working with the QA Distribution organization QMS, to develop, implement and maintain procedures relating to the wholesale distribution activities of distributed products, including Quality Risk Management, Change Management, Document Management, Training, Audit and Management Review
- FVP responsibilities for inbound product release, warehouse storage and outbound deliveries of products to end customers in Switzerland:

- Inbound release of Contrast Media and cold kits to the 3PL warehouse in Switzerland
- Release of short-lived radiopharmaceuticals supplied directly from Manufacturing sites in the EU to end customers in Switzerland
- Managing named-patient supply of unlicensed medicinal products to customers in Switzerland
- Management of all aspects of GDP activities for GE Healthcare AG in Switzerland, including customer and supplier qualification, customer complaints, deviations, investigations and corrective actions, product returns, product recalls and shortages reporting
- Management of outsourced activities - 3PL, local carriers, including supplier qualification, audits and Quality and Technical Agreements
- Liaison with regulatory authorities

Additionally, you will be responsible for the following activities:

- Radiation protection reporting in accordance with the existing BAG license
- Act as WvP person responsible for advertising for products distributed in Switzerland
- Act as Integrity and Transparency Officer (VITH person responsible)

**Your profile**:

- You bring a degree in pharmacology (preferred), or another qualification (higher studies (university or equivalent / higher technical institute) in the area of natural sciences (or if applicable medicine or engineering)) supported by sufficient knowledge and experience in the pharmaceutical sector
- You are eligible to be designated a Fachtechnisch verantwortliche Person (FvP) in Switzerland
- You held the role as Fachtechnisch verantwortliche Person (FvP) in one or more of your previous jobs
- You bring an extensive experience in the pharmaceutical industry, Distribution or Manufacturing environment
- You bring the experience in dealing with competent authorities in Switzerland
- You have strong problem solving skills
- You are experience in auditing (as auditor and auditee)
- High degree of self-motivation and self-responsibility
- Influencing abilities and working within a cross-functional and multi-national team
- You speak and write a business fluent German and English (French at a conversational level is highly beneficial)

**About us**

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

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.

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.

GE HealthCare - Creating a world where healthcare has no limits

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