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Senior Quality Representative (f/m)

Job-ID:500AZG


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Description

Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions.These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.

As team member of Global Quality Control  technical support - method lifecycle management you will:

  • Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
  • Define analytical support requirements (URS, etc) method validation strategy, method performance monitoring process, implementation strategy
  • Oversee and execute method performance monitoring program (performance dashboards, trending etc), oversee and support method investigation, troubleshooting, remediation as required
  • Perform method verification during compendia revision, ensure analytical methods are compliant to relevant compendia
  • Lead and support investigation of laboratory exceptions and support manufacturing investigations in timely manner - Performs complex multi-site investigations and problem solving using DMAIC
  • Ownership of some core QC processes
  • Act as a link between analytical development and the QC labs - transfer methods from analytical development into QC labs
  • Oversee centralized ownership of analytical methods through centralized control and distribution of harmonized procedures
  • Serve as technical SME for responsible programs during agency inspections
  • Conduct work in compliance with cGMPs, safety and regulatory requirements
  • Authoring/reviewing submissions as required

Position located in Vienna or Lexington (Massachusetts, USA)



Qualifications

  • Leadership capabilities
  • Several years of relevant industry experience
  • Works autonomously
  • Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays.
  • Ability to troubleshoot method performance and propose corrections is essential.
  • Background in analytics or natural sciences (university degree or similar)
  • Quality Control and method validation experience
  • Fluent in English and German
  • Excellent communication skills in a cross-cultural and cross-department environment
  • Excellent communication, interpersonal and organizational skills
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask
  • Project management experience would be a plus
  • Self-driven, highly motivated, cooperative and proactive
  • Organizational and problem solving skills
  • six sigma greenbelt or blackbelt would be a plus
  • Project management experience would be a plus
  • Knowledge concerning cGMP (mainly QC related)
  • Willing to travel

 

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is €   3,008.38 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field. Company Insights: https://www.youtube.com/watch?v=Ke-L4TZOujs


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