CAPA Manager

ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

We are seeking a passionate and detail-oriented CAPA Manager to lead the administration and reporting of our Corrective and Preventive Action (CAPA) system. This role is pivotal in ensuring that quality issues are addressed effectively and transparently, while fostering a culture of continuous improvement and compliance.

The CAPA Manager will not own the CAPA actions themselves but will be responsible for overseeing the CAPA process runs in a manner that is compliant with ISO 13485 and associated regulations, ensuring timely and effective execution by CAPA owners, and reporting progress and effectiveness to senior management.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is a primarily an on-site position with some hybrid working at OrganOx’s Giralda Farms US site to ensure the administration and reporting of our Corrective and Preventive Action (CAPA) system is lead effectively.

Major Responsibilities

Under direction from the Director, Quality Assurance, the CAPA Manager will be responsible for:

·       Administer the end-to-end CAPA process in compliance with regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820).

·       Lead, coach and develop a direct report to build technical capability, problem-solving skills and ownership of CAPA administration function.

·       Monitor CAPA progress, ensuring timely closure and effectiveness verification.

·       Drive a culture of accountability for CAPA owners, ensuring actions are completed on time with scalable and sustainable corrective actions.

·       Prepare and present CAPA metrics, trends, and insights to senior leadership. Produce regular data driven reports that identify CAPA trends and feed into process, product or system changes.

·       Facilitate stone cross-functional collaboration to ensure issues are fully understood solutions are well-integrated and learnings are shared across the organization.

·       Maintain CAPA documentation and ensure audit readiness.

·       Leverage Continuous Improvement (CI) tools and methodologies to optimise the CAPA process for efficiency, effectiveness and prevention of recurrence.

·       Drive continuous improvement initiatives based on CAPA learnings.

·       Champion a team-focused, respectful approach to problem-solving and accountability.

·       Adhere to the letter and spirit of OrganOx’s Values, Code of Conduct and all other company policies.

Skills & Experience

·       Effective interpersonal skills to achieve outcomes through influence.

·       Clear communicator both verbally and in writing.

·       Ability to process complex data to enable actionable insights.

·       Demonstrated ability to lead and develop team members, fostering growth and performance.

Qualifications

·       Minimum of bachelor’s degree in a Life Science, Engineering or Technical subject.

·       At least 2 years’ experience in leading CAPA Management with a proven track record of driving CAPA’s to a timely closure and ensuring sustained effectiveness.

·       3-4 years of related work experience in Medical Devices, Pharmaceuticals or other regulated industry.

·       Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others.

·       Ability to travel internationally up to 10%.

·       At least 1 or more years’ of line management experience, managing direct reports.

#LI-Hybrid

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

The Pay Range for this position is $140,000 - $155,000 annually, with a 20% target annual bonus and benefits.

We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.