Job Reference: MG123
Remote Senior Clinical Quality Assurance Specialist
- United States, United States
- £84400 - £84400 per annum
- Permanent / Full Time
Seven Life Science are currently seeking a Senior Clinical Quality Assurance Specialist to work remotely in the United States.
The Sr. Specialist, Clinical Quality role ensures GCP compliance with entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times.
The successful candidate demonstrates knowledge of ICH GCP E6 (R2), is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.
- Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
- Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
- Assure compliance with SOPs and ICH GCP E6 (R2) standards.
- Manages the incident management program through monitoring of complaints, deviations and CAPAs.
- Independently schedules, plans, coordinates and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
- Prepares required documentation to support audit activities including; audit plans, audit reports, audit certificates and corrective action plans
- Accountable for accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
- Reviews the final audit documents for accuracy.
- All other duties assigned.
- Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment.
- Complete understanding and application of ICH GCP R2.
- CQA or other audit certifications are a plus.
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
- Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.
- Knowledge of TMF or electronic document management systems is a plus.
Working with Seven Life Science:
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