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
Skills Required
- Bachelor's degree in Business, Science, or related field or equivalent experience
- 8 to 10 years experience in Quality Assurance
- 4 to 5 years team management experience
- Proficient knowledge of GxP (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
- 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
- Good, well-developed leadership skills and ability to manage and resolve conflict
- Excellent written and oral communication skills; attention to detail, tactful and diplomatic
- Advanced computer skills and literacy
What We Do
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
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