Job Title: Senior Manager Device Supplier Assurance
We are seeking a Senior Manager to lead our Device Supplier Assurance team, responsible for ensuring the quality and compliance of medical device suppliers.
About Viatris
Viatris is a global healthcare company that helps people live healthier at every stage of life. We deliver innovative medicines and solutions to patients around the world, while building a diverse and inclusive workplace culture.
The Role & What You Will Be Doing
In this critical role, you will:
* Develop and manage Supplier Control SOPs aligned with ISO13485, 21 CFR 820 and 21 CFR part 4 compliance.
* Conduct supplier technical assessments and evaluate potential business opportunities.
* Create Quality Technical Agreements and contractual agreements for CMO's and service providers.
* Maintain a supplier technical assessment schedule and approved supplier list.
* Communicate with suppliers on quality and technical issues that impact program timelines or contractual obligations.
* Support project generation, purchasing/supplier specifications.
* Build relationships with internal stakeholders, including Device Development, Device Compliance, Program Management, Legal, Finance, and external Viatris QA, CMO's and service providers.
* Monitor and provide supplier performance trending data for input to GDD Management Reviews.
About Your Skills & Experience
To be successful in this role, you should have:
* A degree in Engineering/Biomedical Science, Engineering or equivalent, with relevant experience in a medical device supplier lead role.
* Experience within a medical devices and container closure systems environment, preferably with drug delivery technologies.
* Strong technical report writing skills, sound problem-solving abilities, and excellent communication skills.
* Proficiency in speaking, comprehending, reading and writing English is required.
* Attention to detail in all aspects of supplier management and a systematic approach to tasks.
What We Offer
Viatris offers a competitive salary, benefits package, and an inclusive work environment where you can use your experiences, perspectives, and skills to make a difference in the lives of others.