Finland Global Clinical QA Manager
Finland Global Clinical QA Manager
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Job Description
Mission
In this role you will provide direct support to the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP pharmacovigilance and other related activities. The individual will provide compliance support to Clinical Development (Clinical Operations Data Management Biometrics Data Science Safety/PV) overseeing the GCP audit programs and developing maintaining and continuously improving the GCP Quality System. Participate in internal audits and global regulatory inspections including FDA/EMA. As a subject matter expert for specific Good Clinical Practices. Through the of these operations you will ensure compliance with GCP and other relevant regulations contributing to the realization of Happiness with Vision for people around the world.
Essential Duties and Responsibilities:
- Support continuous improvement of quality processes and systems that ensure compliance with clinical studyrelated activities in collaboration with contract research organizations and inhouse clinical development.
- Design Clinical QA folders for all development studies that are easy to navigate and identify. Locate current and archive files from the Quality documentation system (VQDVeeva vault) and file them into a new filing system. Maintained Clinical Quality documentation.
- Support preparations for and followup of effective audits of investigator sites essential documents (Protocol IB Master Template Inform Consent CSR) Trial Master Files vendors and internal processes.
- Provide effective oversight of systems crossfunctionally in clinical research and development in collaboration with matrix team members (attend internal Study Team Meetings and corresponding external study meetings).
- Ability to identify evaluate and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution.
- Support training staff and external partners in compliance current clinical practices and procedures.
- Maintained annual Internal audit schedule and external Audit Schedule in the Annual audit plan. Manages corresponding workflows and ensures documentation is maintained per procedures. Assist in vendor audits and CAPA followups and closure.
- Promote collaboration internally and with external partners to ensure all systems processes and their outcomes comply with applicable international and national standards regulations and guidelines.
- Support GCP inspection readiness & Provide inhouse GCP training.
- Travel required 2530 .
Qualifications :
- 6 years of experience in Clinical Quality Assurance Quality Assurance or Clinical Operations within Pharma or Biotechnology industry. Experience with all phases of clinical trials.
- Broad knowledge of riskbased quality systems consistent with Good Clinical Practice. Ability to identify and resolve quality issues.
- Attention to detail as well as crisp clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fastpaced highgrowth environment.
- Bachelors degree in a scientific field
- Fluent English language skills.
- Experience supporting inspectionreadiness activities (FDA HC & EMA) is a plus.
Additional Information :
Deadline
Please apply before 31st March 2025.
To submit your application please upload your English version of CV (click on Apply and follow the instructions).
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
