Associate Director, Clinical Quality Assurance

divh2Associate Director, Clinical Quality Assurance/h2pAt 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 Kaileras 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./ppWhat Youll Do:/ppPlaying 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./ppResponsible to collaborate/support 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 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./ppRequired location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month)./ppResponsibilities:/pulliIn 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))/liliMonitor and track quality metrics to identify trends and areas of improvement/liliEnsure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness/liliFacilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program/liliPlan, 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/liliAssess audit findings and develop corrective and preventative actions (CAPA)/liliLead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA/liliEnsure that investigations are conducted in a timely and thorough manner, following established procedures/liliDevelop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections/liliProvide guidance and support to cross-functional teams during Health Authority inspections/liliCollaborate 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/liliProvide training and guidance to cross-functional teams on GCP/GVP regulations, Quality Assurance procedures, and audit protocols/liliServe as a subject matter expert on GCP/GVP quality assurance matters/liliParticipate in the selection and evaluation of vendors, ensuring that they meet quality standards and regulatory requirements/liliReview and approve GCP/GVP-related documentation, including study protocols, study reports, and other relevant documents/liliEnsure that documentation is accurate, complete, and compliant with regulations/liliFacilitate/participate in Quality Oversight Committee meetings with vendors and develop and maintain quality agreements with vendors/li/ulpRequired Qualifications:/pulli10+ years of experience in FDA regulated industry/liliPrevious hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required/liliA strong customer focus and ability to prioritize and adapt to business needs are required/liliStrong business partner with a focus on collaborating and delivering results/liliSelf-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities/liliUnderstanding and knowledge of applicable industry regulations/liliAbility to interact constructively and efficiently within and across functional areas and management/liliAbility to resolve day-to-day issues efficiently while maintaining compliance/liliClear, concise writing skills and good verbal communication and presentation skills/liliComply with Company quality standards/SOPs and implementation of new quality systems/liliProvide imaginative, thorough, and practical solutions to problems/liliSolve conflict and address workplace issues in professional and collaborative manner/li/ulpEducation:/pulliBachelors degree required/li/ulpSalary Range: $160,000 - $200,000 USD/ppFor Full Time Roles: This range represents the companys 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 grantsbecause your well-being and future matter to us./ppEqual Employment Opportunity Information: Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances./p/div