Position: Director/Senior 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 Director/Senior Director, Quality GCP will be responsible for strategic and operational management of the GCP Quality group, in compliance with US (FDA) and International (ICH) regulations and Guidance, as to ensure that the appropriate processes, systems and activities are performed to protect the rights, safety and welfare of our clinical patients; to oversee, assess and directly work to continuously improve GCP quality processes; and support the state of GCP compliance at Karyopharm. Key expectations are for this role to lead in driving Karyopharm’s GCP and PV activities to meet the defined quality objectives, as well as to audit and assess the GCP and PV compliance status of our clinical sites, and to ensure that outsourced third parties (CROS and other GCP/PV service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections.
- Develop and lead the GCP Quality organization at Karyopharm, managing, coaching and mentoring direct reports
- Establish/implement clinical quality policies and procedures.
- Provide quality oversight for all external clinical quality systems, including CROs, investigator sites, independent studies, central labs, non-clinical study laboratories and other key partners supporting Karyopharm’s clinical and pharmacovigilance programs.
- Establish metrics for GCP and GLP vendor audit performance and compliance, and partner with the PV group in establishing metrics for internal and external PV operations.
- Provide quality oversight of internal and external clinical functions.
- Develop audit plans and perform audits of clinical, data management/processing, and pharmacovigilance vendors and activities.
- Develop and optimize workflows with Clinical Operations to ensure clear paths of communication, responsibilities, and oversight.
- Manage clinical site and vendor CAPA closure for audit observations, as per the SOP
- Ensure operations in clinical development are compliant with cGCP, cGLP, FDA, ICH, EMA and industry standards
- Review of clinical and data operational plans and protocols
- Review of key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA
- Provide support and contribute to other Quality Assurance activities, as necessary.
- Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study/phase of manufacturing process.
- Promote a culture of continuous improvement, and cross-functional problem-solving
- Propose improvements to Quality Systems, in order to maintain compliance and improve efficiency – utilizing risk-based evaluations and tools.
- Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- Serve as an SME for areas of responsibility during regulatory inspections, and directly manage inspection Ready -Room activities.
- Support corporate and third-party inspection-readiness activities.
- A Bachelor’s Degree (or higher) in Nursing, or an MS (or PhD) in a clinical/medical science, is strongly preferred. Relevant professional certifications are a plus.
- 8-10 years’ experience with Clinical Quality Systems in the drug or biopharmaceutical fields.
- At least 5 years of prior GCP auditing experience of clinical sites, CRO’s and Pharmacovigilance required, with the ability to audit independently, and deliver timely reports and assessments.
- At least 5 years of GCLP auditing of non-clinical study and biomarker laboratories.
- Has lead document review (Source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources, in a compressed timeline to meet corporate objectives.
- Experience in implementation and maintenance of Clinical Quality Systems.
- Demonstrated knowledge of Quality Systems, cGCP, and PV within an FDA and EMA-regulated environment.
- 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 organizations, collaborators and customers.
- Able to handle multiple assignments in a fast-paced environment with changing priorities.
- Available to travel up to 30% of the time (domestic and international).
- Able to influence and work independently, and in a team environment.
- Negotiation and conflict management skills, ability to influence change and process improvements internally and at clinical sites/CROs
- Strong oral and written communications skills as well as presentation skills to leadership and peers at all levels.
- Experience in training staff on GCP and GLP principles, processes and procedures.
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