Senior Director, 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.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Senior Director will partner with the Technical Operations department and external vendors to ensure oversight and compliance to internal SOPs and global regulations.  Senior Director will establish GMP activities related to Drug Substance, Drug Product, packaging/labeling, release testing, stability, and QP release.  Senior Director will develop, continuously improve, and maintain Quality Systems related to GMP activities, maintain documentation for compliance with quality and regulatory standards, and will collaborate closely with internal cross-functional teams and management.  The Senior Director will report to the Head of Quality Assurance.

Responsibilities:

• Define and execute the overall GMP Quality strategy to ensure a consistent and compliant approach for all Kailera programs
• Design, implement, and maintain a comprehensive GMP compliance framework supporting clinical programs and future marketing authorization/registration
• Develop and manage Quality oversight plans and robust processes for all external GMP Vendors and Contract Manufacturing Organizations
• Ensure strict adherence to all GMP Vendor Quality Agreements
• Lead and manage compliance-related activities, including preparatory work for Health Authority inspections, and actively support inspection interactions

• Draft, rigorously review, and approve critical GMP Standard Operating Procedures
• Perform timely and meticulous review and approval of all Vendor and Kailera GMP documentation
• Manage the comprehensive review and approval of executed batch records and associated data for Kailera’s clinical and commercial programs
• Ensure final batch disposition is fully compliant with relevant regulatory filings and internal specifications
• Provide expert QA review of all Chemistry, Manufacturing, and Controls (CMC) sections within regulatory filings
• Review and approve both Vendor and Kailera GMP Quality Events (e.g., Deviations, CAPAs)

• Identify, analyze, and contribute relevant GMP Quality metrics for presentation during Quality Management Reviews
• Evaluate current GMP activities and processes to identify continuous improvement opportunities within the Kailera Quality Management System
• Oversee and manage the day-to-day execution of core GMP Quality Assurance activities.
• Fulfill other Quality Assurance responsibilities as required

Required Qualifications:

• 12+ years of progressive experience in the FDA-regulated Pharmaceutical Industry, with a deep focus on GMP Quality Assurance
• 5+ years of experience managing direct reports and leading team performance
• Expert knowledge of current domestic and international cGMP regulations (21 CFR Parts 210 & 211, Part 11, and EudraLex) and related agency standards as they apply to quality systems
• Proven experience managing or significantly contributing to Health Authority regulatory filings and successful inspection readiness and support
• Proficiency in Quality Management Systems (QMS) software, specifically Veeva QualityDocs and Veeva QMS

• Demonstrated leadership with a proven track record of effectively managing, motivating, and influencing both internal teams and external Vendors/CMOs
• Exceptional written and verbal communication skills, capable of providing sound, experience-based quality advice and clearly articulating complex decisions and justifications cross-functionally
• Strong conflict resolution and collaborative skills to effectively address workplace and interdepartmental issues

• Proven ability to independently determine and develop imaginative, thorough, and practical solutions to complex issues, ensuring alignment with organizational objectives
• Demonstrated agility and flexibility in providing a solution-based approach to emerging challenges and shifting organizational priorities
• Highly organized, self-motivated, and detail-oriented, with a successful history of managing multiple simultaneous projects and priorities

Education:

• Bachelor’s degree in a scientific discipline