Sr. Clinical QA Specialist

Position Summary:

The Clinical Quality Assurance (QA) Specialist is responsible for ensuring the quality and compliance of clinical studies and activities in accordance with applicable regulatory requirements, including FDA 21 CFR Part 812, ICH GCP, ISO 14155, and company SOPs. This role supports the development, execution, and continuous improvement of the Clinical QA program across clinical trials and quality systems in a medical device environment.

Key Responsibilities:

• Ensure GCP Compliance:
  Support and monitor adherence to ICH GCP, ISO 14155, and FDA regulations throughout the clinical development lifecycle.
• Audit Execution:
  Plan, coordinate, and conduct internal and external clinical audits (e.g., site audits, vendor audits, TMF audits) to evaluate GCP compliance and identify areas of improvement.
• Inspection Readiness:
  Assist with FDA and notified body inspections, including preparation, hosting, and follow-up activities.
• CAPA & Issue Management:
  Lead or support CAPA investigations related to clinical quality issues, deviations, and audit findings.
• SOP Development & Review:
  Draft, review, and maintain SOPs, work instructions, and clinical quality policies in accordance with evolving regulations and business needs.
• Vendor Oversight:
  Qualify and assess clinical vendors (CROs, laboratories, eTMF providers) to ensure quality standards are met.
• Training & Support:
  Provide GCP training and quality guidance to internal clinical teams and external stakeholders.
• Risk-Based Monitoring Support:
  Collaborate with cross-functional teams to support risk-based monitoring strategies, clinical trial planning, and data quality assurance.
• Documentation & Reporting:
  Maintain accurate records of QA activities and metrics to support audits, inspections, and regulatory submissions.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Engineering, or related field (advanced degree preferred)
• 3-5+ years of experience in clinical quality assurance within the medical device or pharmaceutical industry
• Strong working knowledge of ICH GCP, FDA regulations, ISO 14155, and relevant global regulatory guidelines
• Clinical trial experience with Class II or III medical devices strongly preferred
• Prior experience conducting audits and working with CAPA systems
• Excellent interpersonal, organizational, and communication skills
• Proficiency in MS Office; experience with eTMF, CTMS, and QMS platforms is a plus
• ASQ or RAPS certifications are a plus (e.g., CCRA, CQA, RAC