Quality Assurance GCP Manager (m/w/d)

Your tasks

As the "Quality Assurance (QA) GCP Manager“ within the GCP and GVP Quality Department, you will play a pivotal role in maintaining and enhancing the quality management framework in alignment with Good Clinical Practice (GCP) guidelines. Collaborating closely with internal teams and external partners, you will ensure regulatory compliance and promote a robust culture of vigilance and safety. Your primary responsibilities will include, but are not limited to:

Audit, Inspection, and Deviation Management:

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Quality Assurance and Compliance:

• Create and regularly update quality standard operating procedures (SOPs), policies, and checklists to ensure compliance with current GCP standards

Risk Management:

• Implement Risk Mitigation Strategies at all levels

Training and Knowledge Development:

• Develop and implement targeted training programs on GCP and quality assurance principles to ensure staff proficiency and compliance

Documentation and Reporting:

• Analyse and present quality metrics and audit findings to senior management to support decision-making