Associate Director, Clinical Quality Assurance

POSITION SUMMARY

The Associate Director, Clinical Quality Assurance (CQA) supports Global GCP QA for Clinical Trial programs.  This position will provide GCP and GCLP quality expertise and operational support for the Clinical Quality function to facilitate GCP quality throughout the clinical research and development space. This role reports to the Director, Clinical Quality Assurance and is a remote based position with a corporate headquarters in Foster City, CA and Parsippany, NJ.

REQUIREMENTS/QUALIFICATIONS

Key Competencies:

  • Oversees clinical trial activities and collaborate with key stakeholder subject matter experts in cross functional study teams to facilitate identification of risks and their mitigation
  • Provides guidance to day-to-day questions arising from clinical trials deliverables
  • Interacts with CROs to ensure adequate quality oversight on clinical activities
  • Collaborate with Clinical Development Operations to drive initiatives relevant to outsourced activities
  • Supports inspections preparation and facilitation in collaboration with other QA groups
  • Performs and supports audits and inspections as well as follow-up activities including CAPA preparation
  • Reviews of clinical quality issues and risk management per ICH E6(R2)
  • Develops and implement clinical quality plans, inspection plans, and tools to assist functions in their daily clinical trial activities
  • Provides and supports education initiative on key GCP requirements

 

EXPERIENCE AND COMPETENCIES

The successful candidate will be able to demonstrate the following:

  • At least 7 years of global clinical quality assurance background in pharma/biotech, specifically in rare disease/ ultra-rare diseases / hematology or oncology and 7+ years hands-on GCP quality experience
  • Prior experience on IEC/ IRB or research compliance programs highly desirable
  • B.S and M.S. in relevant science field, required
  • At least 3 years of experience performing clinical trials, global clinical trial experience and clinical trial auditing experience including CROs, clinical sites and GxP computer validation
  • 5 years of experience performing GCP audits on CROs (including CSV and QMS audit), Clinical Sites, and specialty clinical trial vendors
  • 3-5 years of experience with GxP standards and working cooperatively with a GxP QA team and clinical functions to develop and update QMS and establish clinical quality processes
  • Recently participated in at least 1 Sponsor BIMO or global clinical regulatory authority inspections
  • Current and expert working knowledge ICH E6(R2) and associated ICH Guidelines, as well as global clinical trial regulatory requirements
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple deliverables while maintaining quality and being an advocate for regulatory compliance
  • Position requires a “can do” attitude, highly diplomatic, flexible, and tactful with exceptional critical reasoning skills and flexibility to find creative solutions to complex study issues
  • Ability to use expertise and skills to contribute to the development of GCP Clinical Quality Department, and 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
  • Travel (domestic and international) will be required between 15% to 30%
  • Clinical Auditor certifications, preferred
  • Certified Clinical Risk Management, preferred

 

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions.  Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, a 401(k) retirement savings plan, and an employee stock purchase plan.  Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events.

 

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background.  The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed.  Please note the employment opportunity is not limited to these locations.

Colorado Salary Range: $170,000 to $180,000

New York City Salary Range: $175,000 to $190,000