Clinical Quality Assurance Manager

vor 4 Wochen

Wien, Österreich globe personal services GmbH Vollzeit

Our client is a global pharmaceutical company with around 10,000 employees worldwide. Headquartered in Switzerland, located in 30 other countries, the privately held company supports the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.

R&D efforts are focusing on disease areas where there is still significant need for better treatment options. For the Clinical R&D site located in Vienna/Austria we are currently looking for a
Clinical Quality Assurance Manager (f/m/d)

You have a great interest in clinical quality management and experience in clinical research? You like to work with great accuracy on the documentation of data according to guidelines? Your way of working is analytical? At the same time, you enjoy communicating with people and appreciate being on the road (to audits)? Then this position is an interesting career move for you.

**Responsibilities**:
Provide active support in the continuous improvement at of the Clinical R&D Quality Management System, identify compliance weaknesses, work with staff to identify possible root cause and develop effective corrective and preventive actions

Act as QA representative for operational teams and support functions: Actively contribute to problem solving, give support to operational teams and support functions as regard to quality related issues

Review and give guidance to the development of clinical SOPs owned by CR&D and Global Medical Affairs and ensure that processes described in SOPs are in compliance with applicable regulations

Manage the CR&D training program (maintenance of training records, planning and performance of staff training, organize training sessions)

Evaluate vendor qualification (from QA point of view) to support overall vendor qualification

Perform audits at clinical study sites and vendors supporting clinical studies to evaluate compliance with GCP and with the regulations

Accompany and support regulatory inspections

**Required qualifications and experience**:
University degree (preferably medical or biosciences)

At least 3 years’ experience in the Pharmaceutical or CRO Industry, preferably in Clinical QA or Clinical Operations

Experienced in GCP and Clinical Research

Strong analytical, problem-solving skills with excellent written and verbal communication skills

Strong organizational, presentation, documentation and interpersonal skills

Fluency in English; both - written and oral. An additional language is beneficial.

Team oriented and used to work independently

Willingness to travel up to a maximum of 30%

**The offer**:
**Wide range of benefits**: excellent staff restaurant (Do&Co), parking space, health service, extraordinary stuff events

Flexible working hours, fulltime 38 hrs/week (collective agreement Chemische Industrie)

You benefit from a challenging and rewarding work environment that empowers people to gain important achievements for providing important treatments for patients

International setting with an open, appreciative company culture

Working for a family-owned enterprise with short decision making processes

Not exactly the position you are currently looking for? Please feel free to forward it to friends or colleagues who might be interested in our offer.

globe personal services GmbH
Mag. Claudia Geyerhofer
DC Tower - Donau City Straße 7 in 1220 Wien

M:
+43 (0) 1 - 713 02 77 - 76

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