Senior Manager, 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.

What You’ll Do:

Playing a critical hands-on role within Kailera, the Sr. Manager, 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, 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.

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

Responsibilities:

• Oversee and ensure compliance with GCP/GVP regulations, guidelines, and internal policies throughout clinical trial and pharmacovigilance activities.
• Review and assess clinical and pharmacovigilance processes to ensure alignment with global regulatory requirements (i.e., FDA, EMA, ICH E6).
• 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.
• Prepare for support regulatory inspections related to GCP/GVP activities, including responding to findings and ensuring corrective and preventive actions (CAPAs) are completed.
• Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections.
• Identify areas of risk and implement strategies to ensure compliance with clinical quality standards, regulatory requirements, and industry best practices.
• Provide training and guidance to clinical and pharmacovigilance teams on GCP/GVP standards, regulatory requirements, and internal quality processes.
• Ensure team members stay updated on evolving regulatory guidelines, industry trends, and best practices related to GCP/GVP.
• Partner with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Biometrics, and Clinical Pharmacology and other departments to ensure alignment on quality expectations and GCP/GVP compliance.
• Serve as key point of contact for quality assurance-related issues and provide expert guidance to clinical teams on GCP/GVP matters.
• Promote a culture of continuous quality improvement by identifying opportunities to enhance clinical pharmacovigilance quality systems and processes.
• Conduct regular reviews of clinical pharmacovigilance processes to ensure they remain compliant with applicable regulations and standards.
• Assist in the identification and mitigation of risks within clinical trials and pharmacovigilance processes, ensuring robust risk management strategies are in place.
• Collaborate with stakeholders to implement risk-reduction strategies and continuously monitor risk levels.

Required Qualifications:

• 6+ 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.