What You’ll Do:

Playing a critical hands-on role within Kailera, the Associate Director, Clinical Quality Assurance will be relied upon as 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 to collaborate/support with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biometrics, Clinical Pharmacology and other departments on the implementation of Risk Based Quality Management within assigned program(s); identifying and evaluating the 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 will involve ongoing interaction with internal project team members as well as with Vendors, partners, and project teams, influencing these internal and external stakeholders to successfully embed a strong Quality culture.

Required location: Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities:

• In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies (e.g. through helping to facilitate the identification of critical data and critical data processes, and risks associated with them, establishing, monitoring, and reporting out on Quality Tolerance Limits (QTLS)
• Monitor and track quality metrics to identify trends and areas of 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 clinical programs
• Plan, coordinate, review and approve internal, external, and clinical site audits using 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 appropriate CAPA
• Ensure that 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, Quality Assurance 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 that 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
• Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
• A strong customer focus and ability to prioritize and adapt to business needs are required
• Strong business partner with a focus on collaborating and delivering results
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Understanding and knowledge of applicable industry regulations
• Ability to interact constructively and efficiently within and across functional areas and management
• Ability to resolve day-to-day issues efficiently while maintaining compliance
• Clear, concise writing skills and good verbal communication and presentation skills
• Comply with Company quality standards/SOPs and implementation of new quality systems
• Provide imaginative, thorough, and practical solutions to problems
• Solve conflict and address workplace issues in professional and collaborative manner

Education:

• Bachelor’s degree required