Associate Director, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance

Waltham, Massachusetts

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 develop 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 diverse and talented individuals to join our team.

What You’ll Do:

Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as a subject matter expert in GCP and GVP compliance with respect to the planning, document review, execution, and close-out of Clinical Studies and related drug safety.

Responsible for collaborating with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biometrics, and Clinical Pharmacology and other departments on the implementation of Risk Based Quality Management within assigned program(s); identifying and evaluating remediation of fundamental risks and quality issues internally, at vendors and clinical sites; and collaborating with stakeholders to ensure inspection readiness for assigned programs, laying the foundation for successful outcomes during submission-related and unannounced inspections.

This role involves ongoing interaction with internal project team members as well as with vendors, partners, and project teams, influencing these stakeholders to embed a strong quality culture.

Required location:
Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• In collaboration with internal stakeholders, ensure risk-based quality management is applied to specific studies (e.g., facilitating identification of critical data and critical data processes, and risks, establishing, monitoring and reporting Quality Tolerance Limits (QTLs))
• Monitor and track quality metrics to identify trends and areas for improvement
• Ensure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness
• Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from the clinical program
• Plan, coordinate, review and approve internal, external, and clinical site audits using a risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations
• Assess audit findings and develop corrective and preventative actions (CAPA)
• Lead investigations into quality issues and deviations, identifying root causes and implementing CAPA
• Ensure investigations are conducted in a timely and thorough manner, following established procedures
• Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections
• Provide guidance and support to cross-functional teams during Health Authority inspections
• Collaborate with cross-functional teams to support data integrity during audits, inspections, and clinical trial activities by adhering to GxPs standards and applicable regulations governing clinical data
• Provide training and guidance to cross-functional teams on GCP/GVP regulations, QA procedures, and audit protocols
• Serve as a subject matter expert on GCP/GVP quality assurance matters
• Participate in the selection and evaluation of vendors, ensuring they meet quality standards and regulatory requirements
• Review and approve GCP/GVP-related documentation, including study protocols, study reports, and other relevant documents
• Ensure that documentation is accurate, complete, and compliant with regulations
• Facilitate/participate in Quality Oversight Committee meetings with vendors and develop and maintain quality agreements with vendors

Required Qualifications:

• 10+ years of experience in FDA regulated industry
• Hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS
• Strong customer focus and ability to prioritize and adapt to business needs
• Strong business partner with…