Senior Specialist, Clinical Quality Assurance
Senior Specialist, Clinical QA
- US Remote
- Full Time
Join us today and make a difference in people’s lives!
LivaNova is a global medical technology company built on decades of experience and a relentless commitment to improve the lives of patients around the world. As a worldwide leader in cardiovascular and neuromodulation solutions, we are dedicated to helping create meaningful products and therapies that transform lives each and every day. LivaNova is also dedicated to the highest standards, and we operate at the topmost level of business ethics and compliance.
Our Senior Specialist Clinical QA is an individual contributor role for the worldwide Quality organization having business management responsibility for global Clinical Quality Assurance and Clinical Audits. You will be working with the Clinical Operations and Clinical Project Management Teams to ensure that all processes contributing to the performance of a clinical trial are conducted in accordance with GCPs and other applicable regulations. The focus of the position is to manage all clinical quality assurance related activities, including the clinical specific quality system procedures, training and auditing.
You will be participating in the clinical SOP Review Committee providing input on maintaining and evolving procedures, as appropriate. This position will also align the Global QMS and the Clinical specific quality system procedures to new regulations by editing procedures in accordance with the regulations.
As our Senior Specialist Clinical QA, you will also manage and provide quality review and approval to clinical specific Change Control Board, CAPAs and audit findings including investigations, action plan development, implementation review and effectiveness checks. You will develop, deploy and maintain the global risk based Clinical audit program including acting in the role of auditor. You will develop, provide and maintain clinical specific training materials.
- Provide leadership in evolving policies and procedures to support the Quality vision.
- Assist in the development and deployment of innovative global policies, product/process requirements, and strategies for quality systems.
- Review QMS procedure changes for impact to clinical affairs processes and procedures; review and approve clinical procedures.
- Develop and execute the risk-based Clinical audit program including acting as an auditor and accepting overall responsibility for the program by tracking clinical audit progress guaranteeing its compliance and having an updated and accurate program.
- Support the Clinical Project Management Team(s) during external inspections of the clinical program and/or sites and any required follow-up activities.
- Performs QA and QC review of clinical documentation as requested by the Clinical Project Management Team(s).
- Develop and provide training and mentoring about clinical quality, GCPs and SOPs to clinical department staff and other internal personnel.
- Assist managers in identify and maintaining training requirements for clinical affairs personnel.
- Develop and provide training on GCP/ISO requirements for the sites, as needed.
- Interface with customer quality and medical affairs to ensure reporting requirements for complaints, safety, regulatory reports are met.
- Perform other related duties, including general global QA activities (i.e., outside of the clinical program), as assigned by management.
- Bachelor’s Degree in a science discipline is preferred.
- Background in Life Sciences/Medical Education, or Engineering.
- At least 5 years of experience working in the medical device or pharmaceutical industries.
- Experience in medical device application and approval processes is highly desired.
- At least 2 years of clinical trial experience.
- Experience with GCPs (US, EU and International), regulations, directives, guidelines and standards of clinical investigations.
The world is transforming, and we intend to be seen as the rainmakers of LivaNova innovation. If you feel like you may be a good fit for our team, we want to hear from you.