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Viatris
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here’s how the Quality System Senior Manager role will make an impact:
Manage and maintain the Quality Management System - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization);
Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state performance
Support the management representative, by conducting and reporting on the performance of the QMS at Management Review.
Leads implementation and continuous improvement of the Quality Manual, Quality Policy, CAPA process, Complaints process, Change Control process, Internal audit process, training process.
Leads the implementation of Global Quality Policy introduction / updates in to the local QMS, while providing necessary input, when required, to new / updated Global Policies
Establish and manage the internal audit schedule, while participating in and supporting the execution of Internal audits as necessary
Manage the preparation for, and front third party audits; for example Global Corporate Auditing, Certification / Notified Body audits, Health Authority inspections.
Maintain awareness of ongoing industry best practices, new QSRs and QMSs requirements as they are developed, and implement improvement actions for the QMS, including additional regional requirements to support program delivery
Establish and rollout best practice training to local personnel and relevant affiliate sites, to ensure compliance with local requirements and Viatris Global policies.
About Your Skills & Experience
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
QMS management within the medical device or combination product space. Will consider GMP QS mgmt. experience also
5-7 yrs experience leading Quality Management Systems
Lifescience degree
Auditing experience – hosting 3rd party audits and conducting internal /supplier audits
Experienced at stakeholder management – consider global influence
Desirable: Working knowledge of CFR part 4, 210, 211, EU GMP, 2017/745
Formal training for Internal Auditing (ISO 13485, 2017/745)
Proven leadership of a team with varied experience – juniors to seasoned professional
Able to work in a dynamic environment, with multiple priorities
Experience with Health Authority expectations for standalone medical devices and Combination products
Bachelor's degree
