Quality Systems Manager (m/f/d)

  • Boston, Pieris Pharmaceuticals, Inc.
  • Hallbergmoos, Pieris Pharmaceuticals GmbH
  • Work experience
  • Research, development, teaching
  • Fulltime
  • Published: 24.02.2021
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Pieris Pharmaceuticals (Nasdaq: PIRS) is a clinical-stage biotechnology company with operations in Germany and the United States. Pieris discovers and develops Anticalin® protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies. It is our mission to develop life-changing therapeutic proteins for patients suffering from cancer and respiratory  diseases through the innovative application of novel science and cutting-edge technologies.
 

Your Tasks

  • Administration, support and maintenance of Master Control, the Electronic Document Control Systems and other electronic Quality Management Systems (QMS) that are owned by Quality
  • Managing workflows to support business needs, developing and issuing reports, addressing system issues, implementation of improvements and new modules
  • Oversees the preparation, routing, review, approval, distribution, and archival of new and revised controlled documents
  • Managing and maintaining the Pieris training program

Our Requirements

  • Bachelors’ degree / Associate Degree or equivalent and 5 years’ experience in document processing / document management in a biotech, pharmaceutical, or contract research organization
  • Experience using electronic document management systems (EDMS) required; preferred system is MasterControl
  • Experience in Document Control, CAPA, Change Control, and Training systems
  • Experience with leading implementation and sustainability of Electronic. Document Management Systems, including workflow development and optimization.
  • Fluency in spoken and written English
  • Strong attention to detail and critical thinking ability.

Pieris is a fast-growing biotechnology company with approximately 130 employees across our sites in Munich, Germany and Boston, United States. We work in flat hierarchies with short decision-making paths and offer a working environment characterized by cooperation and innovation. Each of our employees participates in a bonus program based on the achievement of our company goals. In addition, we offer each employee the opportunity to participate in a stock purchase plan as well as a stock option program that allows Pieris employees to benefit directly from the our success.
 
Numerous social benefits such as an additional employer-financed company health insurance, free drinks etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in both of our locations round off our overall package. Creative employee events take place several times a year, as we believe that a healthy spirit of collaboration is key to our success.
 

How to reach us

Zeppelinstraße 3
85399 Hallbergmoos
+49 (0) 811 - 12447 0
  • Frau Ines Lehmann
  • HR Specialist