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Director/Sr Director of QA (GCP) - San Diego (hybrid)

  • Location: San Diego
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted about 2 months ago

Director/Sr Director of QA (GCP) - San Diego (hybrid) - CRO/Biotech - Direct Hire (competitive base salary, bonus, stock, 401k w/match etc.)

A small, growing and very profitable CRO in San Diego, CA are hiring fo a Director or Senior Director of Quality Assurance (QA) to join their team, reporting into C level personnel. This is a direct hire role where the candidate will need to work in the office ~2 days a week, the rest of the time can be remote if required. The role offers a competitive base salary, bonus, stock, 401k w/match etc.

You will meet the following requirements:

  • ~8+ years of experience in Quality Assurance, working within clinical research (pharma, biotech or CRO backgrounds are acceptable)
  • Strong GCP or GXP experience (as an individual not just workin for a company who uses them)
  • Interested in leading the day-to-day QA operations as a working manager and essentially a sole contributor of the QA function. This person should have a vision for their own department and is able to convey standards and expectations within the QA department and to the other departments.
  • Specific experience in leading and conducting clinical study report audits, investigator site audits, clinical data base audits, in-house clinical file audits - not just vendor qualification audits.
  • Happy to be a hands-on leader in a small company; can demonstrate project management skills in manoevering other senior stakeholders/department heads into adhereing to GCP/best practices.
  • Serves as a resource for all functional departments in best practices related to quality systems; and genuinely wants to help fine-tune SOPs in a way that would add value.
  • Experience of implementing new electronic systems (both in-house and with vendors) and takes responsible for maintaining the quality of those systems.
  • Bachelor's Degree

If you meet the above criteria, please apply immediately with your latest resume for instant consideration.