- Serves as a primary contact for consulting to internal teams on issues of GCP and regulatory compliance, procedural document compliance; risk identification and mitigation; quality events reporting and management.
- Leads investigations into incidents of suspected scientific misconduct.
- Participates in identification, assessment, action planning and reporting of serious breaches of GCP and protocol.
- Conducts inspection preparation activities and provides training to investigator site and project team personnel.
- Conducts directed site audits and pre-inspection site preparation visits (minimal travel)
- Manages, supports, and reports on the outcomes of GCP regulatory inspections of investigator sites, clients, and Thermo Fisher Scientific.
- Collaborates with investigator site staff and clients on development and/or review of responses to regulatory authority inspection findings.
- Leads and/or participates in process/quality improvement initiatives.
- Provides mentorship and guidance to junior auditors as appropriate.
Keys to Success:
Education
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Experience
- Previous QA experience (including GCP auditing) that provides the knowledge, skills, and abilities to perform the job (2 years or more) or equivalent combination of education, training, & experience.
Knowledge, Skills, Abilities
- Thorough knowledge of GCP and appropriate regional regulations and guidelines
- Working knowledge of procedural documents
- Strong oral and written communication skills (English)
- Good problem solving, critical thinking, risk assessment and impact analysis abilities
- Able to work independently or in a team environment
- Solid experience in root cause analysis
- Flexible and able to multi-task and prioritize challenging demands/workload
