Director GCP Quality Assurance (m/w/d)
- 4544
- Pharmazeutische Industrie
- Festanstellung
- 01.04.23
- Vor Ort
- Bayern
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English
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Quality Assurance
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Pharma
We are looking for motivated individuals for our client who share values and are motivated to improve the lives of people impacted by cancer.
If you are interested, please send us your application! We are looking forward to your applications!
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Provide support and guidance during and following internal and external audits, and for regulatory inspections
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Lead and plan / strategies inspection readiness activities for a program and project; support inspection preparation on site at sponsor / vendor / site level. Perform / coordinate mock inspection activities
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Provide leadership and direction for ongoing projects, cross-functional teams, and at management review meetings on GCP related activities / issues and act as GCP expert for Constellation / MorphoSys
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Contribute and implement GCP / GVP / GLP compliance risk-based audit strategy and master audit plan. Being part of management, planning, conduct, approval, and close-out of audits (e.g. for a specific clinical development drug program(s) or subtype of audit)
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Provide subject matter expertise and participate in the development and review of Governing Documents (Policies, SOPs etc.)
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Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP / GVP governing documents and related training
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Maintain an in-depth understanding of business principles, industry trends, and the regulatory environment related to GXP activities
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Drive process improvement, provide expertise and consultative guidance on GXP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities
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Represent QA function as assigned in the CTT:
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Participate in the Protocol Deviations (PD) review meetings to identify the trend analysis and recommendations
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Participate in Risk Review meetings to identify the trend analysis and recommendations
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Participate in the vendor management (e.g. qualification, requalification and implementing quality agreements)
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Contribute to the PRC meeting for protocol review
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Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP / GVP governing documents and related training, conduct of internal trainings related to GCP as required
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Lead / mentor membersof GCP / GVP QA
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Ideally experience of 10 or more years within a pharmaceutical drug development GCP- / GVP-related discipline (clinical site and CRO auditing, inspection hosting and management, CAPA and quality management, training, and records management, governing document development and implementation);
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Bachelor’s degree, Masters / Ph.D. optional, in a scientific, health sciences, or quality-related field;
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Knowledge of ICH GCP / GVP / GLP, FDA, EMA, other related ICH, FDA and general compliance and audit concepts;
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Experience at CRO and Sponsor environments would be a great asset;
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Excellent communication skills, both verbal and written;
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Good project management and leadership skills;
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Able to work independently as well as in a cross-functional, multi-cultural team;
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Pro-active, solution-oriented mindset and sound judgment for evaluation of risks, guidance and escalations.
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