Senior Manager, GMP Quality Assurance

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

Requirements

• 8+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex) and other agency standards and guidance as they relate to quality systems/quality assurance
• Proficient in Veeva Quality Docs and Veeva QMS
• Demonstrates proven track record of communication with internal and external Vendors
• Ability to identify quality issues requiring escalation
• Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with objectives
• Flexibility/ability to provide a solution-based approach to emerging challenges/changing priorities
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Vendors in professional and collaborative manner
• Communicate decisions and recommendations with clear justification
• Proactive approach to problem solving

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants