What are the responsibilities and job description for the Quality Specialist CQA position at Groe Advisors LLC?
The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of company clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements.
Position details:
- Strong GCP experience within clinical quality.
- Sponsor-side or CRO experience in the clinical research/pharmaceutical industry.
- Hands-on experience supporting CAPAs, deviations, quality investigations, and issue resolution within a clinical quality environment.
- Experience with clinical quality assurance (CQA), audits, vendor management, and inspection readiness.
- Experience with quality systems such as Veeva and TrackWise, along with a working knowledge of FDA regulations, ICH guidelines, and GxP requirements.
- A willingness to work onsite in Waltham, MA, 3–5 days per week.
Please note: We specifically need candidates who understand clinical quality processes from the sponsor or CRO perspective, as the CAPA, deviation, and quality issue management processes differ significantly from those in site-based or manufacturing environments
Location: Hybrid, 3-5 days/week onsite in Waltham, MA.