Senior Manager Device Supplier Assurance

Posted 7 Days Ago
Be an Early Applicant
Dublin
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Senior Manager Device Supplier Assurance oversees supplier control SOPs, ensuring compliance with ISO13485 and FDA regulations, conducting technical assessments, managing quality agreements, and building relationships across the organization. This role is crucial for monitoring supplier performance and addressing quality issues to meet project timelines.
Summary Generated by Built In

McDermott Laboratories Limited

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager - Device Supplier Management role will make an impact:

  • Responsibility for the generation and management of Supplier Control SOPs aligned with ISO13485, 21 CFR 820 and 21 CFR part 4 compliance, with emphasis on supplier selection, evaluation, & management.

  • Conduct supplier technical assessments identified as technical capability for potential business opportunities.

  • Responsible for the generation of Quality Technical Agreements and contractual agreements for CMO’s and service providers, along with maintenance of MSA’s and CDA’s.

  • Maintain a supplier technical assessment schedule and approved supplier list against business needs.

  • Primary contact for communications, escalation and resolution of supplier related quality and technical issues that may impact program timelines or contractual obligations.

  • Support the generation of projects, purchasing/supplier specifications.

  • Establish a supplier data base against cost, experience, & performance.

  • Building solid relationships within, Device Development, Device Compliance, Program Management, Legal, Finance, & external Viatris QA, CMO’s and service providers.

  • Proactively contribute through ownership of the deliverables of the Quality Objectives defined within the GDD QMS.

  • Monitor and provide supplier performance trending data for input to GDD Management Reviews

  • Manage & execute supplier related change controls and supplier complaints for GDD.

  • Supervision within the Supplier Management group.

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:

  • Degree in Engineering/Biomedical Science, Engineering or equivalent, with relevant experience within a medical device supplier lead role.

  • Experience within a medical devices and container closure systems environment with emphasis on drug delivery technologies would be a distinct advantage.

  • Experience of supplier evaluation & selection against technical need.

  • Excellent technical report writing skills.

  • Sound problem solving abilities.

  • Excellent communicator: clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals and established timelines.

  • Willingness to travel as necessary between the Global Device Development Teams & supplier.

  • 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.

  • Travel to EU, US, India, Taiwan averaging 20% of working year.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

  • Excellent career progression opportunities

  • Work-life balance initiatives

  • Bonus scheme

  • Health insurance

  • Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. 

Viatris is an Equal Opportunity Employer.

Top Skills

Iso13485
The Company
HQ: Canonsburg, PA
16,557 Employees
On-site Workplace

What We Do

Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.

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