Quality Assurance Manager (m/f/d), Document Control and GMP

  • Pieris Pharmaceuticals GmbH
  • Work experience
  • Senior, very experienced
  • Quality Management, Quality Assurance
  • Fulltime
  • Published: 2020-11-26
scheme image

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.

The Manager Document Control and GMP, is responsible for managing, and providing oversight governance to, the global GxP Document Control system ensuring compliance to quality objectives and regulatory requirements. In addition, the Manager supports CMC operations as Quality representative for the clinical development projects. 
 

Your Tasks

  • Serve as the Business Owner and Quality representative for Electronic Documentation Management System (EDMS).
  • Sustain and optimize EDMS and associated processes to support global document control processes and operations. 
  • Serve to the organization as Subject Matter Expert for the EDMS and global document control processes and procedures. 
  • Represent the QA department on CMC project teams. 
  • Manage and address deviations, investigations, corrective and preventive actions (CAPAs), change controls, compliance council meetings, and similar developments, collaborate with CMOs. 
  • Review and approval of master batch records and executed batch records, conduct product release.

Our Requirements

  • Bachelor’s degree in Life Sciences required, Master’s degree preferred 
  • 5 years of technical writing/document control preferably in Mastercontrol
  • QA experience in a cGMP manufacturing environment 
  • Experience with leading implementation and sustainability of Electronic Document Management Systems, including workflow development and optimization, preferably with Mastercontrol. 
  • Knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical development and operations. 
  • Fluent English (spoken and written) 
  • Strong team player with flexible and positive attitude. 

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
  • HR Project Manager
  • Ms. Cathrin Grolig