Responsible Person

vor 3 Wochen

Zug, Schweiz Gilead Sciences Vollzeit

For Current Gilead Employees and Contractors:
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Internal Career Site

**Job Description**:
Responsible Person - RP (M/F/d)

Gilead Sciences is a biopharmaceutical company that has been pursuing breakthroughs in medicine for more than three decades with the goal of creating a better, healthier world for all people. In this context, the company focuses on developing innovative medicinal products for the prevention and treatment of severe and life-threatening diseases. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Gilead in Switzerland is a high performing affiliate and a key market of the Australia, Canada and Europes (ACE) Midsize Markets region. The Gilead office in Zug is responsible for the quality, registration as well as medical, sales and marketing activities for our products in Switzerland. In order to ensure the high standard of quality of the Swiss affiliate we are looking for a new Responsible Person (RP) ideally as of 1 June 2023 due to the retirement of the current position holder.

The role:
As the Responsible Person, you will be responsible for maintaining the operating licences of Gilead Sciences Switzerland Sàrl for its medicinal products as well as for its gene therapy products in accordance with the Swiss Medicinal Products Licensing Ordinance (MPLO) and the Therapeutic Products Act (TPA) as well as the Transplantation Act. You will also ensure that the requirements of all relevant national and international guidelines and internal specifications are met.

In your function as RP, you make your decisions independently of the Management, but in close cooperation with the national and international partners. You are familiar with scheduling, preparing, executing and completing the diverse tasks of quality assurance.

You communicate changes in quality information to project teams and senior management and you initiate or contribute to local and / or global process improvements which have a significant impact on the business.

In your function as RP you will be responsible for:

- the direct technical supervision of the facility
- Management of local Quality Management System (QMS)
- assuring the appropriate handling of the medicinal products / gene therapy products
- the quality of the medicinal products/gene therapy products and monitoring that these comply with the applicable specifications and are manufactured in accordance with the rules of Good Manufacturing Practice (GMP)
- the market release of the finished medicinal products
- the shipping of medicinal products in accordance with the rules of Good Distribution Practice (GDP)
- QA review & approval of local Affiliate Change Controls, Deviations & CAPAs
- Management of local recall activities and execution/participation in periodic mock product recall challenges.
- Management/Coordination of local complaints & falsified products investigations
- the supplier management and supplier audits including distribution partners in Switzerland
- the drafting and renewing of quality agreements with internal manufacturers and/or external partners
- assuring that the implemented quality management system is always up to date
- the annual planning & execution of self-inspections and GDP training courses
- the Quality/Risk Management
- the conducting of Quality Management Reviews
- the assessment of Annual Periodic Product Reviews (APQRs) in accordance with the Swiss marketing authorisation
- the verification of the authorizations of new customers/changes as well as the annual review
- Hosting inspections by the cantonal authorities and Swissmedic as well as corporate GDP/GMP audits

Your profile and personal skills:

- A university degree in pharmacy, chemistry, biotechnology or other natural sciences.
- Experience in an international environment and comprehensive knowledge of international and local quality systems as well as legal regulations and standards for pharmaceutical products and medical devices
- Experience as a Responsible Person or as a deputy
- 5 years of professional experience in QA, of which at least 2 years in the Swiss market
- Excellent influencing and negotiation skills,
- Capable of taking a leadership role in updating and preparing the Company for major changes in legislation
- High quality awareness, accurate, independent and reliable approach to work
- Ability to work in a team, work under pressure, flexibility and good communication skills
- Recognized as an expert resource for Advice in other departments
- Very good stylistically appropriate command of written and verbal German and very good command of English
- Command of French and/or Italian would be an advantage.

Gilead Values:

- Integrity (Always doing the right thing)
- Teamwork (Collaborating in good faith)
- Excellence (Working at a high level of commitment and capability)
- Accountability (Taking personal responsibility)
- Inclusion (Encouraging diversity)

As an equal opportunity employer

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