12 days ago on roche.com

Team Leader Product Development Quality Services

Roche AG

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 Please refer to JobSuchmaschine in your application

Team Leader Product Development Quality Services

Team Leader Product Development Quality Services

Switzerland, Basel-Town, Basel

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  • Job facts

We in Product Development Quality Services (PDQS) provide services that enable the company to operate to required clinical, safety and quality standards.

We do this by:

  • Developing and deploying SOPs and associated training
  • Designing and delivering GCP/PV training
  • Managing systems to support SOP and training deliverables
  • Supporting GCP/PV inspection readiness and managing inspections end-to-end

This Team Leader position is part of the Standards and Process Governance Team who are responsible for Developing GCP & GVP Process and Procedures.


  • Implements the controlled document strategy for PDQ and the supported business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance
  • Develops Standards, Policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials
  • Leads the team of SOP Managers and SOP Specialists. Provides line management support for direct reports and consistently capitalizes on opportunities to recognize or coach each individual to higher performance
  • Establishes, maintains and fosters strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions
  • Is knowledgeable of all services and activities provided by PDQ QS, Standards & Processes in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    University degree in Science-related subject or other related field. Advanced degree preferred.

    • >7 years in the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development
    • Experience in preparation, development and administration of GxP standards and processes
    • Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills
    • Effective communication and influencing skills and leading with and without authority
    • Can successfully manage cross-functional and interdisciplinary teams and projects
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Quality & Compliance
    • Subfunction Quality Systems
    • Schedule Full-time
    • Job level Manager
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Date 2016/10/13
    • Job-ID 3242710249
  • Get in touch
    Mathieu Vetter+41 61 688 41 00
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Apply now!