Director/Senior Director, Clinical Quality Assurance

Cambridge, MA

JOB TITLE: Director/Senior Director, Clinical Quality Assurance
EFFECTIVE DATE: August 15, 2019
CLASSIFICATION: Exempt
FUNCTIONAL AREA: Clinical Development
WORK LOCATION: Cambridge, MA
SUPERVISOR: Head of Regulatory Affairs (or Delegate)
MANAGERIALLY RESPONSIBLE FOR: N/A

ESSENTIAL JOB FUNCTIONS:

  1. Lead the GCP function at Kura, responsible for directing and managing clinical QA activities.
  2. Develop, implement and maintain GCP quality systems.
  3. Design, plan and execute risk-based audit strategies.
  4. Responsible for qualifying vendors and service providers.
  5. Identify and write CAPAs, appropriately monitoring CAPAs through resolution.
  6. Ensure implementation of industry-standard electronic document management systems.
  7. Lead the development, implementation, maintenance and training of SOPs and various work process guidance in partnership with other functions.
  8. Design and oversee inspection readiness efforts; assist with the preparation and conduct of Regulatory Authority inspections.
  9. Provide training and education to clinical personnel and project teams on proper quality assurance.
  10. Ensure sponsor and service providers meet all regulatory requirements, achieve high quality standards and continuously pursue improvement.
  11. Assist Clinical Operations in formulating responses to quality observations/findings.
  12. Participate with group managers in establishing strategic organizational plans and objectives.

 

JOB SPECIFICATIONS:

  1. Candidates should have minimum B.A./B.S. preferably in a scientific discipline.
  2. At least 7 to 10 years of experience in the pharmaceutical/biopharma industry working in Quality Assurance.
  3. Significant knowledge of global regulations and guidance in clinical research.
  4. Experience in supporting global Regulatory Authority inspections.
  5. Experience in supporting clinical trial GCP compliance and clinical quality management activities.
  6. Proficient in the principals of risk management.
  7. Previous experience conducting or supporting clinical site and/or vendor audits.
  8. Excellent planning, organization and time management skills including the ability to support and
  9. prioritize multiple projects.
  10. Excellent interpersonal skills in addition to verbal and written communication skills.
  11. Strong leadership skills, self-motivated, responds well under pressure and adaptable to a dynamic environment.
  12. Working knowledge of GxP regulations, including USA (FDA), EU (EMA and MHRA), ICH Guidelines and RoW.
  13. Flexibility to travel up to approximately 10% of time.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to careers@kuraoncology.com