OMEICOS Therapeutics GmbH - Head of Quality Assurance & Clinical Research Manager (m/f)

Head of Quality Assurance & Clinical Research Manager (m/f)

Role & Responsibilities
•    Implementation and ongoing development of quality management system (GxP) with focus on GCP according to progress of clinical study program
•    Creation and implementation of SOPs/POLs and development of essential quality documents
•    Preparation and performance of internal and external audits (at CROs, providers) in order to ensure compliance with GxP requirements
•    Responsibility for training of internal staff on QA requirements
•    Support by preparation and/review of clinical study documents, e.g. study protocol, data management plan / SAP,  clinical study reports
•    Support by evaluation of clinical data results and data management activities


 Professional experience and personal skills
•    University degree in Life-Science or similar qualification
•    Proven work experience of at least 3 years in the fields of Quality Assurance with scope on GCP and Clinical Research
•    Strong familiarity with clinical documents, in particular in the data management field; experience in medical writing would be an advantage
•    Work experience in pharmaceutical / biotech company or CRO
•    Deep knowledge and expertise in regulatory requirements for clinical development
•    Strong communication and interpersonal skills as well as demonstrated hands-on mentality
•    Excellent English skills written and spoken; fluency in German would be an advantage


What is offered?
•    Employment in a dynamic start-up company with flat hierarchies 
•    Direct involvement in company’s development program
•    Opportunity to improve and develop  quality management system as the position holder will take over the system from the current initial status
•    Professional environment as member of a scientific driven team

Your application:
If you are looking for a new career challenge and a future-oriented role, then we are looking forward to receiving your application including your earliest possible starting date and salary expectations.
Please send your application exclusively via email to the attention of Dr. Robert Fischer, Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!


Earliest entry date: 1st of September 2017


OMEICOS Therapeutics GmbH
Robert-Rössle-Straße 10
13125 Berlin