Manager/Senior Manager, Quality Assurance, Bioanalytical

• 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

• 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

• 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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. 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.