Associate Director, Clinical 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.

Responsibilities:

Oversee and ensure compliance with GCP/GVP regulations, guidelines, and internal policies throughout clinical trial and pharmacovigilance activities

Develop and implement quality assurance plans and strategies for clinical studies and related activities

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

Qualifications:

Minimum of 10 or more 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

Proficiency in Microsoft Word, Power Point, Excel, Adobe, and SharePoint

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 a professional and collaborative manner

Education:

Bachelor’s degree required

Salary Range

$155,000 $190,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is a…