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Global Clinical Quality Assurance Director
2 months ago
ADC Therapeutics SA is seeking an experienced Executive Director of Global Clinical Quality Management to lead our global quality assurance strategy and ensure compliance with Good Clinical Practice (GCP) and regulatory standards.
Key Responsibilities- Develop and implement global quality assurance policies and procedures that comply with GCP and regulatory requirements across different regions.
- Lead and manage comprehensive audit programs, including both routine and for-cause audits, to ensure adherence to GCP and regulatory compliance.
- Oversee preparation and response strategies for both US and ex-US regulatory inspections.
- Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans.
- Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices.
- Serve as the primary quality assurance liaison with regulatory authorities, partners, and internal stakeholders.
- Bachelor's degree in Life Sciences, Pharmacy, or related field. An advanced degree (MS or PhD) is preferred.
- At least 20 years of experience in clinical quality assurance within a global organization, including extensive GCP-focused work and managing international audits and inspections.
- Certification in Quality Assurance such as CQA or RQAP-GCP preferred.
- Experience with PV Quality preferred.
- Experience in hematology/oncology trials preferred.
- Extensive knowledge of ICH GCP and relevant global regulations and guidelines with the ability to apply the principles.
- Expert knowledge of GCP, FDA, EMA, and other international regulatory standards.
- Experience interacting with inspectors and cross-functional, global teams is required.
- Experience in working with an outsourced model for clinical trials is preferred.
