Pieris Pharmaceuticals (Nasdaq: PIRS) is a publicly-traded, clinical-stage biotechnology company with operations in Germany and the United States. Pieris specializes in the discovery and development of 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, immuno-oncology multi-specifics tailored for the tumor microenvironment, and a half-life-optimized Anticalin protein to treat anemia. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies.

To strengthen our team, we are looking for an experienced:

Clinical Quality Assurance Manager (m/f/d)

Your Tasks

  • Quality Assurance oversight of the clinical operations and other GxP activities to assure clinical trials are initiated, documented and reported in compliance with internal SOPs, GxP regulations and industry guidelines.
  • Develop and maintain GCP/ICH compliant processes which control the quality of work and the clinical trials 
  • Represent Quality on the clinical sub-teams, providing input and GCP compliance. Troubleshoot clinical trials and activities.
  • Evaluate quality events, incidents, queries, and complaints.
  • Create and maintain internal and external audit plan. 
  • Lead or assist auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, agency regulations. Communicate any critical compliance risks noted from these activities to senior management.
  • Actively lead or assist activities in the areas of Self Inspections, CAPA (Corrective and Preventive Actions), Quality Management Reviews and Quality Audits.
  • Create and maintain the training records for all GxP personnel including to update training matrix and maintain oversight of employees performing GxP tasks and qualification based off training.
  • Support special projects requiring QA input.

Our Requirements

  • University degree within a life science related discipline
  • 5+ years’ industry experience in Clinical Quality Assurance
  • Expert knowledge of GCP, familiarity with GCLP and GMP
  • Strong interpersonal skills
  • Working experience in a global team and ability to work in a matrix environment
  • Highly proficient in negotiation skills and effective in influencing others
  • Fluency in spoken and written English
 
We are a fast-growing biotechnology company with approximately 130 employees at our sites in Freising (Greater Munich Area) and Boston (USA). 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 individual and company-wide goals. In addition, we offer each employee the opportunity to participate in a stock savings plan and a stock option program that allows employees to benefit directly from the company's success.
 
Numerous social benefits such as additional employer-financed company health insurance, free drinks, fruit baskets etc. as well as a bright, friendly and ultra-modern working environment with excellent technical equipment in our new company building in Hallbergmoos (from February 2020) round off our overall package. Creative employee events take place several times a year, as team spirit is essential for us. The joint creation of an innovative and participative corporate culture is an important concern for us.