Director, Clinical Quality Assurance

POSITION SUMMARY

This position reports to the Vice President, Quality and supports the company’s Oncology programs. The Director, Clinical Quality Assurance will provide GXP compliance expertise and leadership for the Quality Assurance group and ensure that Geron’s products, processes, facilities, and systems conform to appropriate quality standards and governmental regulations. This is a remote based position with a corporate headquarters in Foster City, CA and Parsippany, NJ.

REQUIREMENTS/QUALIFICATIONS

Key Competencies:

  • Develops and maintains GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy
  • Ensures clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements
  • Manages Clinical QA departmental staff and contractors
  • Manages and oversees all aspects of Clinical QA at clinical vendors
  • Creates, manages, and maintains quality plans for the Clinical QA department
  • Manages and conducts quality audits of investigator sites and various clinical vendors
  • Manages and conducts quality audits of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms
  • Manages inspection readiness and BIMO inspection activities for organization
  • Manages and conducts internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines
  • Provides expert Clinical QA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations
  • Supports the administration of the company's training program by conducting GCP training to internal departments and externally, as applicable
  • Manages and conducts targeted training of investigators/site staff
  • Reports GCP related deficiencies to senior management as well as plans for corrective and/or preventive actions (CAPA)
  • Assists clinical study teams in the development of CAPAs
  • Assists with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management
  • Coordinates responses to regulatory agency inspections

EXPERIENCE AND COMPETENCIES

The successful candidate will be able to demonstrate the following:

  • 10+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
  • 7+ years hands-on CQA/GCP Compliance experience
  • Bachelor’s Degree in relevant science field, Master of Science is preferred
  • Position requires a highly diplomatic, tactful, and detail-oriented individual with exceptional critical reasoning skills
  • Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving
  • Domestic travel will be required, approximately 20%
  • Auditor certifications, a plus