Senior Product Manager – Clinical Operations
Veeva Systems
Google Cloud PlatformVault
Clinical Quality Assurance Associate
WEP Clinical
full-time
Posted on:
Origin: • 🇺🇸 United States • North Carolina
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud PlatformVault
About the role
- Ensure GCP compliance and promote best practices across all regulated activities.
- Initiate and contribute to deviations, complaints, CAPAs, risk assessments, and validation protocols.
- Investigate deviations and complaints, and follow up on CAPAs to ensure timely resolution.
- Review clinical trial documents (e.g., protocols, ICFs, eCRFs) and essential records for accuracy.
- Review eTMF for completeness and accuracy, working with staff to resolve any deficiencies.
- Support clinical and nursing operations in managing QMS records, including change controls and risk management.
- Identify root causes of quality issues and recommend appropriate solutions.
- Assist in training staff on QMS components and relevant procedures.
- Provide daily support on quality-related queries and maintain GxP documentation.
- Support vendor qualification and requalification, including audit preparation and participation.
- Contribute to internal audits and regulatory inspections as a subject matter expert.
- Generate quality metrics, analyze trends, and support process improvements and validation strategies.
Requirements
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 0-3 years of experience in a Quality-related role, with practical exposure to GCP activities
- Familiarity with eTMFs (e.g., Veeva Vault) and proficiency in Microsoft Office
- Strong organizational skills with keen attention to detail
- Knowledge of ICH GCP guidelines and relevant regulatory requirements (e.g., FDA)
- Effective verbal and written communication skills
- Self-motivated and proactive, with strong interpersonal and critical thinking skills
- Able to manage multiple tasks and deadlines with accuracy
- Discreet and trustworthy with confidential information
- Experienced in cross-functional collaboration for investigations, root cause analysis, and process improvement
