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Kailera Therapeutics · 1 day ago

Associate Director, Clinical Quality Assurance

Waltham, Massachusetts

Full-time

Hybrid

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera is committed to advancing novel therapies for obesity and related conditions, fostering an inclusive workplace. The Associate Director, Clinical Quality Assurance will serve as a subject matter expert in GCP and GVP compliance, collaborating with various departments to ensure quality management and inspection readiness for clinical studies.

BiotechnologyPharmaceuticalTherapeutics

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 program

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

Qualification

GCP complianceGVP complianceVeeva Quality DocsRisk Based Quality ManagementFDA regulated industryQuality Assurance proceduresClear writing skillsVerbal communicationProblem-solvingCollaboration