The Clinical Trials Division (CTD) of Thermo Fisher Scientific is focused on providing end to end clinical trial solutions for our customers. We don’t specialize in any particular therapy – we support them all. Our customers range from small biotech/pharmaceutical startups that lack expertise beyond R&D to large companies who prefer to outsource these services. We have the industry’s largest global footprint of FDA cGMP facilities close to clinical trial hubs around the globe so we can be where our customers need us - we provide the full suite of services in each of those hubs because we know there’s a patient waiting.
This role supports the VP, Quality Assurance and Regulatory Affairs, in driving process consistency and process integrity throughout the global CTD quality system. The role will liaise with site Quality teams, Operations personnel, Global Customer Quality Leads, external quality consultants, and customer quality functions when necessary.
- Support the development, implementation and ongoing use of globally aligned Standard Operating Procedures (SOPs); sponsor authorship of new SOPs as needed within the business.
- Coordinate with and manage external quality consultants from a global perspective, as appropriate, in supporting the CTD quality system.
- Drive the metric development and reporting process for Quality on a global level; analyze and report on trends and recommendations.
- Support the Management Review process as needed.
- Drive the agenda and content management for the monthly Quality Council calls in close cooperation with the VP Global QA, ensuring value-added topics and trainings to ensure development of and relevance to the team.
- Drive Practical Process Improvement (PPI) within the quality teams; ensure proper prioritization of issues identified and implementation of solutions globally (or as broadly as applicable).
- Support the internal and external audit process as needed.
- Coordinate with VP Global QA and site Quality leadership on CTD Global Policy development and deployment.
- Bachelors degree in chemistry, life sciences, pharmacy or related field
- Minimum 10 years of quality-based experience in clinical research/GXP environments
- Demonstrated quality orientation within prior work environments; prior experience working effectively with large customers with regulated environments
- Strong project management skills
- Excellent communication skills, both written and oral; effective presentation skills
- Strong orientation around process development and implementation, with a demonstrated ability to execute actions globally; a bias for action
- Strong problem-solving skills and attention to detail
- Demonstrated success with organizational change, preferably in a matrixed culture
- Multi-cultural exposure
- Previous audit experience is a plus
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