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.
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