Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
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.

What You’ll Do:

QA Bioanalytical Team Direction and Management

Driving QMS and Process Improvement Initiatives

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

Hosting Sponsor Audits and Regulatory Inspections

Actively contributing to Global QA Strategy

What You’ll Bring:

Ability to communicate and interact at all levels within multicultural environment

Ability to organize and manage multiple priorities

Strong problem solving, comprehension and analytical skills

Collaborative team player, open minded, ethical and culturally sensitive

Ability to manage and resolve conflict

Good, well-developed leadership skills

Excellent written and oral communication skills

Attention to detail, tactful and diplomatic

Advanced Computer skills and literacy

What is Required:

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

Minimum of 8 to 10 years experience in Quality Assurance

Minimum of 4 to 5 years team management 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

If this role is what you are looking for as the next step in your career, then please apply!
Celerion Values:       Integrity   Trust   Teamwork   Respect   Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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