Job Description
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.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
