Senior Manager, Global Device Quality

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

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.

Our Global Device Development organization is an innovative, technically strong, and fully integrated team focused on delivering high-quality, safe, and effective device and combination products to meet evolving patient healthcare needs worldwide. It provides leadership, strategic oversight, direction, support, and hands-on training for medical devices and combination products. Through a thorough knowledge of practices appropriate to the quality systems, computerized data management practices, and global regulatory expectations, this position will provide global leadership to establish, maintain, and implement Viatris’ Global Quality Standards in a manner which meet/exceed global regulatory requirements. This position will partner with Quality, Global Device Development, Pharmacovigilance, Operations, Regulatory Affairs and various other management personnel across all business units in all regions of Viatris.

Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Global Device Quality will make an impact.

Key responsibilities for this role include:

• Provide leadership and drive continuous improvements in quality system practices throughout the corporation to meet/exceed global regulatory requirements for medical devices and combination products.

• Align with other top-level managers in the development and establishment of corporate-wide Quality initiatives, continuous improvement programs, and key performance targets.

• Serve as a subject matter expert regarding best practices in Quality Management Systems and Conformity Assessments for medical devices and combination products.

• Evaluate, implement, and execute systems for standardizing compliant practices. Provide global oversight of standardized systems and perform "in use" verification of such global systems.

• Participate in activities in support of global inspection preparedness, audit response and CAPA related to local and global systems impacting medical devices and combination products.

• Interact with Regulatory Authorities (Health Authorities and Notified Bodies) in a thoughtful and professional way, while leading medical device submissions and notified body interactions.

• Ensure compliance with medical device post-market surveillance and vigilance requirements (EU & US).

• Act as Person Responsible for Regulatory Compliance (PRRC)

• Collaborate with quality colleagues and other departments during all phases of integration activities, including the assessment of documents, processes, and systems.

• Monitor regulatory trends and identify industry “best practices” for relevant medical device and combination products and governing QMS.

• Create, review and continually improve global medical devices and combination product SOPs and policies to ensure global approach remains compliant and in line with state of the art.

• Review and/or approve site SOPs to ensure alignment with global policies and procedures, and applicable standards and regulations.

The minimum qualifications for this role are:

• Extensive experience in global cGMP regulations and quality systems across US FDA, EU, Health Canada and AUS/NZ regulatory environments.

• Strong working knowledge of medical device and combination product regulatory requirements, including EU MDR, FDA regulations, 510(k) submissions and CE conformity assessment activities.

• Experience leading quality and compliance functions within pharmaceutical and medical device organisations, including management of third-party suppliers and external partners.

• Proven ability to interpret and apply regulatory requirements, lead complex compliance discussions and drive corrective and preventive actions across cross-functional teams.

• Strong leadership and people management experience, including performance management, team development, hiring and organisational planning.

• Effective written and verbal communication skills with the ability to engage confidently with regulators, auditors, senior stakeholders and business partners.

• Proficient in Microsoft Office applications including Word, Excel and Outlook.

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.

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 offercompetitivesalaries, benefitsandan 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.