Director – Global Device Quality

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.

Every day, we rise to the challenge to make a difference and here’s how the role 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 device 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.

• Function as a change leader within the Quality organization on the local and global levels to raise awareness and compliance with Viatris’ expectations and strategy for elevating quality via continuous quality improvement.

• Serve as a subject matter expert regarding best practices regarding the areas involved in Quality Management Systems for device 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 devices and combination products.

• Interact with Health Authorities and Notified Bodies in a thoughtful and professional way.

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

• Monitor regulatory trends and identify industry “best practices” for required device and combination products.

• Develop training strategies and content to perform on-site and computer-based training of key personnel.

• Create and review global SOPs and policies.

• Review site SOPs to ensure alignment with global policies and procedures.

• Position requires international travel as necessary.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) in a science related discipline and minimum of 10 years of experience in an analytical, quality, or manufacturing environment. A Master’s degree (or equivalent) and minimum of 15 years relevant experience in Research and Development, Quality and/or Regulatory Affairs preferred. However, a combination of experience and/or education will be taken into consideration.

• Must possess knowledge of national, international, and supranational cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations. Must be familiar with all concepts related to assigned quality systems.

• Must be articulate in both written and oral communications, including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Strong interpersonal relationship and diplomatic skills required. Must be proficient in leading discussions of complex topics. Must have computer skills with working knowledge of Microsoft Office including Word, Excel, and Outlook.

• Position reports to the Head of R&D and Technical Quality. Position functions semi-autonomously with direct supervisory responsibilities. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Quality certifications preferred.

• Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to collaborate with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.

• Ability to perform computations such as percentages, ratios, and rates, as well as perform statistical analysis. Ability to draw and interpret graphical data. Ability to understand pharmaceutical calculations is preferred.

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

• Typically sitting at a desk or table. Intermittently sitting, standing, walking, or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.  Sedentary lifting requirements.

• Periodic travel is required.

• Normal office situation

• Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00 USD.

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. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.