6 days ago on idorsia.com

GxP Quality Systems Manager

Idorsia Pharmaceuticals Ltd

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GxP Quality Systems Manager

Job Description

Job Title: GxP Quality Systems Manager

Job Reference number (Job ID): PD1814

Posting Date: 13.02.2018

About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to
help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical
company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and
development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad
portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center,
and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly
qualified specialists dedicated to realizing our ambitious targets.

Job Title
GxP Quality Systems Manager

Job Responsibilities

  • Manage/supervise the Systems and Compliance Team within the department of Pharmaceutical
    Development to create a dynamic and effective team focused on providing GxP compliant
    computerized systems used specifically for QA audit/reporting, Quality Management, QRM and
    electronic archiving purposes
  • Take the lead from a QA perspective, in projects driving the migration of legacy systems/records to
    new Idorsia technologies and subsequent retirement of outdated systems, liaising with our GxP QA
    groups, CVS QA and IT
  • As the appointed system/business owner, take responsibility for initial validation of the
    system/module(s) and their subsequent management in accordance with GxP regulations and
    Idorsia CSV procedures
  • Design, organize and execute appropriate training materials to system users with regard to the
    Quality Management System and all associated QM modules
  • Apply advanced knowledge and experience to address complex issues; developing new
  • Ensure that QS documents related to the Quality Management System are defined, created,
    maintained and implemented in accordance with GxP regulations and Idorsia requirements Ensure
    users satisfaction by gathering/analyzing feedback and implementing adequate measures
  • Promote the systems internally and perform presentations/reports to cross functional audiences
  • Represent the Systems and Compliance Team during regulatory inspections with regard to
    applicable Quality Management system(s)

Candidate’s Requirements

  • Bachelor degree in Science, Information Technology and/or a Business Degree

  • At least 10 years’ experience in the pharmaceutical industry including direct responsibilities in the
    implementation, validation and management of computerized systems in a GxP environment

  • Familiar with the design and management of computerized systems used within a GxP environment
    specifically for quality management purposes. Systems in scope include automated QA
    audit/reporting tools, quality management systems and QRM tools (e.g. management of quality
    system documentation (polices, SOPs etc.), staff training records, change control records, deviation
    management, CAPA management, technical complaints etc.)

  • Experience in the use and management of systems specifically used for electronic archiving would
    also be advantageous
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  • Fully conversant in the application and interpretation of requirements such as GxP, 21 CFR Part 11,
    GAMP5, EU GMP Annex 11

  • Excellent interpersonal and leadership skills as well as written and verbal communication skills

  • Ability to work as an individual or as part of a team with focus on providing a customer oriented

  • Ability to independently deal with complex and difficult situations

  • Ability to work under pressure and prioritize tasks

  • Excellent command of written and spoken English, German would be advantageous

What Idorsia offers

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous social benefits

Data Privacy
By applying you signify you have read and agreed our Data Privacy Policy which is available on our
WebSite at the following page: https://www.idorsia.com/careers/faq/privacy-policy

Work Location: Allschwil
Country: Switzerland
Business Area: Pharmaceutical Developmet
Schedule: Fulltime
Job Type: Permanent

If you are interested, please send your CV and motivation letter by email to
idorsia.careers@idorsia.com clearly stating the job title and reference of the position to which you are
applying in the subject line.

Please be informed that if you are selected for this position, your employment will be subject to a pre-
employment background screening process, of which you would be informed in greater detail in due

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those
partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited
resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to
personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries,
affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not
subject to payment of any form of introduction, placement or referral fees.
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