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Manager/Senior Manager, Quality Assurance, Bioanalytical

celerion Lincoln, NE

See all open roles at celerion

Ghost-risk verdict

Some ghost-posting signals

  • open for 146 days (90+ without a fill is a strong ghost signal)
  • 48 open roles at this company in 30 days (mass-hiring blitz)
  • no salary disclosed (correlates with ghost postings)

How we score ghost risk →

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About the role

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

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