Quality Assurance GCP Manager (mwd)

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
• Support the preparation and management of regulatory inspections and contribute to maintaining inspection readiness
• 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

• Several years of experience in GCP quality assurance or related fields within the pharmaceutical industry or a Health Authority
• Experience in planning and conducting GCP audits
• Degree in Life Sciences Pharmacy or a related field
• Extensive knowledge of GCP guidelines ICH-GCP standards and global regulatory frameworks (e.g. EMA FDA MHRA etc.)
• Strong understanding of clinical trial methodologies and quality management systems
• Ability to work independently build strong stakeholder relationships and provide pragmatic quality guidance in a dynamic clinical development environment.
• Exposure to computerized system validation (CSV) activities and oversight from a QA perspective would be advantageous but is not essential
• Excellent written and verbal communication skills in both German and English (C1 or above)

• Supportive respectful and appreciative work atmosphere in a small dedicated team
• Diverse learning culture and individual development opportunities
• International and growing family business with short decision-making processes financial independence and long-term perspective
• New work flexible working hours and mobile working
• Wide range of benefits (free beverages health and sports benefits canteen JobRad)
• Comprehensive onboarding and mentoring program