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Clinical Quality Assurance Specialist

1 month ago

Reston, Virginia, United States Bayside Solutions Full time
Clinical Quality Assurance Role

Bayside Solutions, Inc. is seeking a highly skilled Clinical Quality Assurance professional to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:

  • Collaborate with clinical functions to support GCP compliance and ensure the quality of clinical trial documents.
  • Participate in clinical study execution teams to enable risk-based quality management and a culture of quality and open dialogue.
  • Perform quality reviews 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.
  • Support Inspection Readiness activities and assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct.
  • Escalate identified issues to QA Management as needed.
  • Enable other assigned GCP or GXP-related tasks, as appropriate.

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 an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity and promotes equal opportunities for all employees.