Manager Clinical Quality Assurance (m/f/d)
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 a
Manager Clinical Quality Assurance (m/f/d)
Research & Development
Your new challenges which will inspire you:
- Support continuous improvement at CR&D, identify compliance weaknesses and work with staff to identify possible root cause and develop effective corrective and preventive action plan
- Maintenance of the SOP system in CR&D (support development/updating of SOPs, manage approval process, SOP distribution and filing), 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)
- Ongoing quality support to CR&D staff and provide QA input to special projects in CR&D as necessary
- Perform QC review of clinical documents (study protocol, study report, master informed consent)
- Support management of contractors (initial qualification, ongoing quality review, contractor audits)
- Perform clinical study audits (e.g. at CRO, study site, central lab), including planning, performance, reporting and follow up open corrective and preventive actions until completion
- Assist in preparation, conduct and follow up of regulatory inspections
- Keep informed about most regulations and guidelines pertaining to GCP and clinical trial activities including EU and US regulations
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 Operations
- Experience in quality management desirable (certified quality manager and quality auditor)
- Practical experience in clinical QA desirable
- Strong analytical, problem solving skills with excellent written and verbal communication skills
- Strong organizational, presentation, documentation and interpersonal skills
- Good clinical knowledge with an understanding of medical terminology
- Solid understanding of applicable guidelines and regulations for clinical studies
- Advanced level of computer literacy (MS office applications, understanding of databases, understanding of computerized systems validation requirements)
- Excellent English
- Team oriented
- Willingness to travel (travel time up to 60%)
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 wage according to the collective agreement (chemical industry) for your new job is EUR 3.270,89. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages 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
As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.In 2018, the Group achieved €1.8 billion in revenue, an operating income of €346 million and invested €204 million to ensure future prosperity. Octapharma employs more than 8,300 people worldwide, 1,200 of them in Vienna, to support the treatment of patients in 115 countries with products across three therapeutic areas:
- Haematology (coagulation disorders),
- Immunotherapy (immune disorders) and
- Critical Care.
Octapharma owns six state-of-the-art Production facilities in Austria, France, Germany, Mexico and Sweden.