Senior Manager Clinical QA Lead
Vor 2 Tagen
We are seeking a highly skilled Regulatory Compliance Specialist - Clinical QA to join our team at Incyte. The successful candidate will be responsible for providing GCP oversight of Clinical Development teams and executing and managing Incyte QA GCP audits.
Key Responsibilities:- Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
- Plan, schedule, and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates, and Clinical submission documents.
- Conduct GCP training for Incyte staff.
- Assist with the maintenance of the Clinical Quality Management System, including QA support for change control, deviations, review/revision of SOPs, and continuous process improvement.
- Coordinate responses and corrective/preventative actions from deviations, audit, and regulatory findings.
- Stay abreast of EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
- Alert Global QA Clinical Upper Management of internal and external GCP non-compliance and clinical trial issues in a timely manner.
- Be knowledgeable and familiar with assigned Incyte compounds and protocols.
- Provide support for regulatory authority inspections (or audits by partner), including conducting pre-inspection audits and inspection readiness activities as assigned.
- Bachelor's degree in a science or healthcare-related discipline or similarly conferred degree from a University.
- 2 to 10 years' experience in a pharmaceutical or bio-pharmaceutical company in a GCP Quality Assurance role or Clinical compliance role.
- Minimum of 1 year experience performing GCP audits of investigator sites and/or CROs or comparable GxP audits experience.
- English fluency written and spoken (the company language).
- Knowledge of other languages, such as French, is an asset.
- Ability to travel up to 30%.
- Prior GCP Regulatory inspection experience would be a plus.
- Strong written and oral communication skills.
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