Celerion

Manager/Senior Manager, Quality Assurance, Bioanalytical

Celerion  •  Lincoln, NE (Hybrid)  •  1 month ago
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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 ManagerSenior 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.
Celerion

About Celerion

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.

Our operations are strategically located in:

Lincoln, Nebraska (Corporate Headquarters)

Philadelphia, Pennsylvania

Phoenix, Arizona

Belfast, Northern Ireland,UK

Zurich, Switzerland

Vienna, Austria

Richmond, Virginia

Montreal, Quebec, Canada

For more information, visit: www.celerion.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Lincoln, NE
Year Founded
2010
Website
celerion.com
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