Quality Assurance Associate
vor 2 Monaten
**Your Role**:
You are responsible to support the development, implementation, maintenance, and monitoring of Quality Management Systems (QMS) and activities in the execution of Quality Assurance deliverables. As well you are supporting the Quality Assurance department, through assisting with audit activities in support of ongoing quality improvement. You act as a liaison with other business units and partners and assumes some responsibilities for Quality led initiatives, based upon knowledge of regulations, standards, and industry best practices.
- Assist in the management of GCP quality systems which include the following:
- Oversight of Standard Operating Procedures
- Updates to current and development of new SOPs
- Management of SOP training programme
- Implementation of systems to assess compliance with SOPs and facilitate improved compliance where necessary
- Assist the management of Work Instruction documentation
- Review internal records (e.g. employee training records, study files, etc) for compliance with SOPs and applicable regulations, guidelines, and ITM policies
- Facilitate implementation of non-QA document and data review process to ensure compliance while maintaining efficiency
- Provide GCP compliance advice and guidance to Team members to achieve continuous quality improvement
- Assist internal GCP inspection readiness activities to prepare for clinical sponsor inspection, investigator site inspections
- Assist with development, implementation, and maintenance of robust and proactive GCP quality management system, including development of standard operating procedures and work instructions related to clinical research conduct
- Stay up-to-date with new and revised regulations and trends in industry standard
- Assist with establishment of training procedures, development of functional area training matrix and documentation of training
- Track training compliance of clinical functional areas and provide quarterly training metrics to Quality.
- Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups
- Support the development and delivery of GCP training programs
**What we are looking for**:
- Bachelor’s degree required in a scientific, health sciences, or quality-related field
- Minimum of 3-5 years industry experience in a clinical compliance, QA or operations role
- Working knowledge of FDA, EU and other global regulations and guidance governing Good Clinical Practice (GCP)
- Experience conducting GCP inspection readiness activities and/or hosting EMA and/or FDA GCP inspections is a plus
- Ability to execute and follow-through to completion and documentation
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem solving ability
- Flexibility and excellent organizational skills in an extremely fast-paced environment with changing priorities
- Excellent communication skills and ability to influence across multiple functions
- Strong interpersonal relationship and collaboration skills working within cross-functional teams
- Enthusiasm, determination and intuitiveness
- Organized, self-directed, efficiency-minded and detail-oriented
- Very good knowledge of the common Microsoft programs (Word, Excel and Outlook)
- Excellent written and spoken English (native speaker is a plus) and good knowledge of German
**What we offer**:
- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits
At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.
Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.
Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?
Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.
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