Sr Quality Compliance Officer GCP
Neuchatel, Switzerland
vor 9 Tg.

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We’re currently looking for a :

Sr Quality Compliance Officer, GCP With the following requirements

  • University degree in Life Sciences, Biology, Chemistry or equivalent
  • Strong experience in clinical Quality Assurance in the life sciences or the pharmaceutical industry
  • Proven lead auditor experience.
  • Thorough knowledge of ICH Good Clinical Practice and Good Pharmacovigilance Practices

  • Proven success in leading people or teams
  • Ability to foster a strong collaborative culture with all stakeholders
  • Strong interpersonal skills and ability to communicate confidently at all levels
  • Practical problem-solving and strong organizational and prioritization capabilities
  • Self-motivated and able to function both independently and within a team
  • Fluent in English (written and spoken), French desired If you possess the above mentioned profile then you are the one we want to meet for staffing our Quality, Regulatory & Standards Management Department, within the Quality Compliance team in Philip Morris Products S.
  • A., based in Neuchâtel, Switzerland.

    As a Sr Quality Compliance Officer, you will be responsible for the Quality Assurance (QA) of Good Clinical Practice (GCP) and Good Epidemiological Practice (GEP) at PMI’s R&D Neuchatel facility, but also for compliance oversight of the Product Safety & Surveillance (PSS) function.

    You will establish and maintain a QA program for GCP and GEP in conformance with national and international regulations and the applicable PMI internal quality management standards (QMS).

    Your specific responsibilities will be :

  • Align the QA program with R&D strategy and its deployment across the organization.
  • Collaborate across departments and with key stakeholders to ensure targets are achieved

  • Plan, schedule, perform and report routine and non-routine process, systems and study-based audits to assure quality management that internal systems and processes are in accordance with relevant international requirements for GCP and GEP
  • Perform QA review of SOPs and other quality documents for compliance with GCPGEP in order to verify their conformance with the PMI QMS for Reduced Risk Products (RRP) and applicable regulations.
  • and harmonize QA SOPs and other quality documents to align with the PMI Quality Organization, as required

  • Manage inspection preparedness together with management to ensure that the Clinical Science and Epidemiology organization is ready at all times for regulatory inspections
  • Support study teams and other stakeholders by providing consultancy on compliance issues
  • Review, approve and follow-up Corrective and Preventive Actions, including from Non-Conformances, audits and inspections
  • Provide support in the implementation of data integrity requirements and validation of computerized systems supporting GCP studies Why work for us?
  • Here are 3 reasons PMI is the ultimate Employer :

    1.We’re international :

    you work with clients and learn on-the-job from team members from all over the world2.We’re flexible :

    your work fits you and not the other way round, thanks to our Flexible Work Arrangement Program and3.We’re a certified top employer :

    we consider our employees to be our strongest asset, and we are developing talent throughout all levels of the organization.

    As the first multinational company in Switzerland to obtain the Equal-Salary label, for men and women, our competitive salary and compensation package is for all our employees.

    JOIN A GLOBAL MARKET LEADER If you wish to contribute to the future of our business and to the new scientific journey of the industry, please apply online.

    PMI is the world’s leading international tobacco company, with six of the world's top 15 international brands and products sold in more than 180 markets.

    In addition to the manufacture and sale of cigarettes, including the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of Reduced-Risk Products ( RRPs ).

    RRPs is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking.

    We have a range of RRPs in various stages of development, scientific assessment and commercialization.

    Because our RRPs do not burn tobacco, they produce far lower quantities of harmful and potentially harmful compounds than found in cigarette smoke.

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