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Quality Assurance Manager
hace 3 meses
Mission: Provide advice, maintenance, oversight, and continuous improvement of the company Quality System, ensuring compliance with applicable regulations and guidelines.
Functions and Responsibilities:
- Establish and maintain a Quality System for Clinical Trial activities, aligning with the relevant departments to ensure compliance with applicable regulations.
- Develop GCP global quality plans, audit plans, and risk mitigation strategies based on risk assessments.
- Coordinate, document, and follow up on defined audits.
- Lead, assist, or oversee audit activities as necessary.
- Lead the preparation and management of inspections by Competent Authorities and audits performed by third parties.
- Identify and communicate quality and regulatory compliance issues to the relevant management and recommend remediation.
- Participate in Clinical Study Teams and specific Project Teams.
- Select, coordinate, and oversee outsourced Quality Assurance activities applicable to clinical trials.
- Stay updated with current regulations, standards, and guidance documents.
- Contribute to technical guidance, leadership, mentoring, and training as a key stakeholder in quality and compliance matters.
Education: Bachelor's/Master's degree in Health Sciences, Biological Sciences, or a related field.
Experience and Requirements:
- Minimum of 5 years of experience in GCP.
- Knowledge of GVP is a plus.
- Experience in dealing with Health Authority inspections and audits by external parties.
- Willingness to travel up to 15% of the time.
- Fluency in English, both written and spoken, is essential.
- Detail-oriented and analytical mindset with a clear focus on meeting timelines and objectives.