Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team:
Manager Clinical Quality Assurance (m/f/d)
Your new challenges which will inspire you:
- 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
Your profile that will convince us:
- University degree (preferably medical or biosciences)
- At least 3 years’ experience in the Pharmaceutical or CRO Industry, preferably in Clinical QA or Clinical Operations
- Strong analytical, problem-solving skills with excellent written and verbal communication skills
- Strong organizational, presentation, documentation and interpersonal skills
- Excellent English
- Team oriented & willingness to travel (travel time up to 50%)
Our attractive benefits for you:
- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market.
- Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
The minimum gross salary according to the collective agreement (chemical industry) for your new job is EUR 3.557,47. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay salaries higher than collectively agreed.
We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life – because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.
Mag. (FH) Charlotte Ponzer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien
T: +43 (1) 610 32 – 1301