Director, Global Device Quality

Role Summary

Director, Global Device Quality is a leadership role responsible for guiding global quality systems and regulatory compliance for device and combination products. The role drives continuous quality improvement, aligns with senior management on corporate-wide quality initiatives, and functions as a change leader to elevate quality across the organization. The position serves as a subject-matter expert on Quality Management Systems for device and combination products and provides global oversight of standardized practices. The role requires collaboration with health authorities, cross-functional teams, and international travel.

Responsibilities

• Provide leadership and drive continuous improvements in quality system practices throughout the organization 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 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.

Qualifications

• Required: 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.
• Preferred: A Master’s degree (or equivalent) and minimum of 15 years relevant experience in Research and Development, Quality and/or Regulatory Affairs. 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.
• Proficiency in speaking, comprehending, reading and writing English is required.

Skills

• Strong interpersonal and diplomatic communication skills
• Ability to lead discussions of complex topics
• Proficiency with Microsoft Word, Excel, and Outlook
• Ability to interpret regulations and provide guidance
• Independent decision-making
• Collaborates effectively with executives and cross-functional teams

Additional Requirements

• Periodic travel is required.
• Physical demands: typically sitting at a desk; may be required to stand, walk, stoop, bend, kneel, and climb steps; use of hands and arms; sedentary lifting requirements.
• Proficiency in English (speaking, comprehension, reading, and writing) is required.