Manager/Senior Manager, Quality Assurance, Bioanalytical

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

Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations. If you find one there, mark it as "Not Junk" to ensure future Celerion emails land in your inbox. Please note that Gmail accounts have been particularly noted as routing to Spam.