Clinical Quality Assurance Contractor
W2 Contract
Location: Remote Role - PST
Job Summary:
You will play a key role in Quality Assurance by providing compliance support for sponsored clinical trials concerning Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.
Duties and Responsibilities:
- Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to support GCP compliance.
- Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
- Perform quality review of clinical trial documents focusing on compliance, regulatory requirements, and risk management.
- Collaborate with internal stakeholders, internal or external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
- Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
- Provide support for Inspection Readiness activities.
- Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct, including but not limited to investigations, root cause analysis, CAPA planning, and management.
- Escalate identified issues to QA Management as needed.
- Enable other assigned GCP or GXP-related tasks, as appropriate.
- Support GCP audits, inspections, vendors, and clinical investigator sites by regulatory authorities or business partners.
Requirements and Qualifications:
- Bachelor's degree in a scientific or technical discipline
- 12+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry with a focus on audit management, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities
- Extensive knowledge of ICH GCP, other relevant ICH guidelines, and regulatory requirements (FDA, EMA) regarding applicable drug development regulations
- Effective verbal and written communication skills
- Able to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
- Able to critically evaluate and troubleshoot complex problems with diligence.
- Highly proficient with various Microsoft Office and other computerized systems, including Word, Outlook, Excel, PowerPoint, and Visio
- Knowledge of Computer System Validation is preferred.
Desired Skills and Experience
Clinical Quality Assurance, GCP, FDA, EU, ICH, regulatory inspection, audit management, drug development, Microsoft Office, Computer System Validation
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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