Philip Morris International (PMI): Manager QA - Switzerland

Manager QA

YOU are a highly motivated, passionate team player who is always committed to deliver work of the highest quality. You have a flexible, solution-oriented personality with an analytical mind that enjoys problem-solving. You have a strong customer focus and seek a creative and international work environment.


THE OPPORTUNITY
You will join the Quality Assurance (QA) team of Philip Morris Products S.A. in Neuchâtel, Switzerland and will be part of the PMI Research & Development Department, whose primary mission is to research and develop new products with the potential to reduce the risks of smoking-related diseases.
You will develop and drive the implementation of a GxP-compliant Quality Management System (QMS) throughout PMI’s Research and Development (R & D) department. You will also manage the establishment and maintenance of a QA Unit to support clinical studies.

Specifically, you will:

• Support the establishment and maintenance of quality standards, to assess compliance with GxP principles and internal PMI R&D QMS
• Lead and manage the establishment of a QA Unit to support clinical studies and to ensure compliance with Good Clinical Practices (GCP) and local regulatory requirements
• Lead, plan and manage internal (i.e. sponsor) and Contract Research Organization audits to verify compliance with GCPs and PMI R&D QMS
• Verify and/or support GxP compliance of computerized system validation and change control according to established regulations and guidelines such as GAMP5 and 21CFR11
• Advise on and guide the establishment and continual improvement of internal procedures
• Perform internal and supplier (i.e. Contract Research Organization) audits to assess compliance to the PMI R&D QMS and GxP principles
• Create, update and/or review Standard Operating Procedures and Work Instructions
• Remain up-to-date with the evolution of the regulatory framework concerning GxP principles, in particular GCPs and other relevant quality standards


QUALIFICATIONS
• Honors / Masters degree in Life Sciences
• Substantial practical experience in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices , Biotech or Food
• Experience in clinical trials/studies and ICH and/or FDA Good Clinical Practices is a must
• Working knowledge of International Conference on Harmonization (ICH)  Q8, Q9, Q10 and Efficacy Guidelines, in particular E6
• Practical experience in conducting audits in the context of clinical trials/studies
• Demonstrated understanding and hands-on experience reviewing technical documents, including validation plans and documents, IQ/OQ/PQ protocols and reports would be an asset
• Experience in people leadership, budget- and project management
• Fluency in both written and spoken English is a must; proficiency in French would be an asset.

WHAT WE OFFER

PMI R&D offers a state-of-the-art working environment in our brand new research center in Neuchatel, Switzerland. Our employees are engaged in world class scientific and industry leading product development projects. We develop and realize individual career plans and we support specific development needs of our employees through internal and external learning opportunities.
We offer an excellent salary and benefits package as well as a relocation allowance (where appropriate).


WHO WE ARE
Philip Morris International Inc. (PMI) is the leading international tobacco company, with seven of the world’s top 15 international brands, including Marlboro, the number one cigarette brand worldwide.  PMI’s products are sold in more than 180 markets.  In 2012, the company held an estimated 16.3% share of the total international cigarette market outside of the U.S., or 28.8% excluding the People’s Republic of China and the U.S. PMI is an Equal Opportunity Employer.  For more information, see www.pmi.com

Want to discover your potential? Come join our team!
 
If you match our profile and you are interested in joining our dynamic team of professionals, please apply online at www.pmicareers.com
 
A valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position.

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