Senior Quality and Compliance Specialist (Remote)

Job Specific Skills

• Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates
• Understanding of how to plan, prepare and conduct GxP audits independently
• Ability to support clients with development or refinement of Quality Management Processes or Systems
• Project management as it relates to quality and compliance activities
• Proficient in authoring and managing audit documents independently
• Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently
• Assists in other duties relating to overall compliance within Quality and Compliance department, as requested
• Must be willing to travel up to 30% of the time for audits within the US; must also be willing to travel internationally as needed

Requirements

• College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduate
• Minimum of 5 to 7 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor)
• Expertise within CROs, scientific and clinical data/ terminology, and the drug development process
• Experience with project oversight including but not limited to; document management, vendor qualifications, training management
• Proficiency with MS Office applications
• Hands-on experience with clinical trial and pharmaceutical development preferred
• Good communication skills and willingness to work with others to clearly understand needs and solve problems
• Excellent problem-solving skills
• Good organizational and communication skillsProficient with applicable regulatory requirements
• Must have strong technical writing skills