* Leads or contributes to the risk-based quality assurance program's strategic direction.
* Support and continuously improve the GCP quality management system.
* Conduct audits and manage effective audit programs
* Audit internal and external systems
* Coordination of the design, execution, and reporting of outsourced audits with external
auditors
* Organise and take part in inspections of government agencies or potential partners.
* Monitoring the non-compliance process, managing corrective and preventive actions (CAPA),
and coordinating quality issues with all internal functions and departments
* Assist with supplier selection and qualification.
* Expertise and/or advice on GCP issues is provided to development teams.
* Maintains and develops the company's SOP system within the document management system,
including SOP review and validation, to ensure compliance.
* Plan, organise, and record SOP and GCP-training
Your Profile:
* Scientific, pharmacy, or medical degree
* At least 5 years of experience in the pharmaceutical industry in quality assurance management
of clinical and non-clinical activities (including CMC) during development (Phase 1-3) prior to
validation.
* Excellent knowledge of GxP regulations in Germany, Europe, and the United States.
* Outstanding communication, teamwork, and leadership abilities
* Excellent organisational and intercultural skills
* Work that is flexible, scientific, and willing to grow professionally on a regular basis
* English fluency
