Position: Associate Director/Director, GCP Quality
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Associate Director/Director, GCP Quality will be a member of the GCP Quality group, and is responsible for management of the GCP Audit Program and CAPA management, in compliance with US and International regulations and Guidance, ensuring that the appropriate processes, systems and activities are performed to ensure the rights, safety and welfare of our clinical patients, to ensure that Karyopharm’s GCP quality objectives are met, and to ensure that Karyopharm and outsourced third parties are always audit ready.
- Provide quality oversight for external GCP-Quality activities, including CROs, investigator sites, independent studies, and other key partners supporting Karyopharm’s clinical programs.
- Draft/implement clinical quality policies and procedures.
- Establish metrics for GCP vendor audit performance and compliance. Perform Periodic trending of vendor performance data and present, as needed
- Develop audit plans and perform audits of clinical, data collection and processing, and pharmacovigilance vendors and activities.
- Develop and optimize workflows with Clinical Operations to ensure clear paths of communication, responsibilities, and oversight.
- Review and source-data verification of key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA (CSR)
- Manage and confirm that GCP CAPA are complete and closed for audit observations, as per the SOP
- Ensure operations in clinical development are compliant with cGCP, FDA, ICH, EMA and Global standards
- Review of clinical and data operational plans and protocols
- Keep abreast of changes to GCP Regulations and Guidance, and apply internally, as needed.
- Provide consultation in interpretation of regulations/guidelines as they apply to the GCP practice, awareness of regional regulatory requirement, and phase of study/phase of manufacturing process.
- Promote a culture of continuous improvement.
- Propose quality improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based assessments.
- Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- Serve as an SME for areas of responsibility during regulatory inspections and directly support regulatory inspections
- Support Internal, Clinical Site and CRO inspection-readiness activities.
- A Bachelor’s Degree (or higher) in Life Sciences, Pharmacy, Nursing, or in a relevant medical/clinical field is required.
- 10 or more years’ experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.
- Over 5 years prior independent GCP auditing experience at Clinical Sites is required
- Experienced in performing internal audits of GCP processes and functions
- Demonstrated knowledge of GCP Quality Systems and oversight of GCP within an FDA and EMA-regulated environment, including Risk-Based management of Clinical Activities
- Experienced in the implementation and maintenance of GCP Quality Systems.
- Experienced in partnering with other departments, to drive closure of GCP CAPA
- Must be well-organized and able to grasp system concepts and communicate their applications.
- Excellent oral and written communication skills for effectively interfacing with internal and external peers, consultants and organizations.
- Able to handle multiple assignments in a fast-paced environment with changing priorities.
- Able to travel up to 25% of the time (domestic and international).
- Able to influence cross-functional peers and leadership
- Able to work both independently and in a collaborative and dynamic team environment.
- Experienced in training and coaching internal and external staff on GCP principles, processes and procedures.
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