Manager/Senior Manager, Quality Assurance, Bioanalytical

We're seeking a talented Manager/Senior Manager, Quality Assurance, Bioanalytical for our Global QA department to drive quality and compliance of our studies, processes and systems which is key to our mission of accelerating medicine for patients.

Ideally this role would be locally based at our Lincoln, Nebraska US location or alternatively at our Tempe, Arizona US location. Hybrid working and willingness to travel from other locations in the United States would also be considered.

Are you a Bioanalytical Quality Professional with experience in quality assurance and team management looking to make an impact in a dynamic clinical research environment?

At Celerion, we're transforming clinical research through translational medicine. We're seeking a talented Manager/Senior Manager, Quality Assurance, Bioanalytical for our Global QA department to drive quality and compliance of our studies, processes and systems which is key to our mission of accelerating medicine for patients.

Ideally this role would be locally based at our Lincoln, Nebraska US location or alternatively at our Tempe, Arizona US location. Hybrid working and willingness to travel from other locations in the United States would also be considered.

If this role is what you are looking for as the next step in your career, then please apply!

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• Bachelor’s degree in Business, Science, or related field or equivalent experience

• Proficient knowledge of GXP (specifically GLP and/or GCP) and FDA 21 CFR Part 11 regulations

• Robust knowledge of Bioanalytical techniques, regulations and industry guidelines

• Well-developed Pharmaceutical Industry network
• QA Bioanalytical Team Direction and Management

• Oversight of Study Audits, System/Process Audits and Vendor Audits

• Actively contributing to Global QA Strategy
• Ability to communicate and interact at all levels within multicultural environment

• Strong problem solving, comprehension and analytical skills

• Collaborative team player, open minded, ethical and culturally sensitive