[Hiring] Manager, Global Quality Investigations @Viatris

Role Description

The Manager, Global Quality Investigations role will make an impact by:

• Performing real-time review of investigations/post market complaints to determine the investigations’ robustness and ensure the implementation of appropriate corrective/preventative actions based on appropriate root cause and assessment of impact.
• Reviewing and participating in the investigations associated with critical quality events/escalations and providing guidance for continuous compliance and quality improvement.
• Reviewing and participating in the investigations associated with supplier non-compliance/escalation and providing guidance for continuous compliance and quality improvement.
• Timely reporting of analyzed data through governance and appropriate escalation of critical findings to global and regional quality management.
• Performing assessment of Global SOPs/Policies with site SOPs and communicating to sites with opportunities for enhancements.
• Preparing and presenting monthly metrics summary for all key attributes associated with investigations review.
• Routinely interacting with all stakeholders at site, regional, and global levels.
• Staying current with industry standards and interpretations of key regulations and applying all applicable learnings in review process enhancements.
• Monitoring and responding to key performance indicators from the investigational metrics across the assigned regions/sites in order to mitigate business risk.
• Position requires 10% - 20% domestic/international travel or as necessary.

Qualifications

• Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. A combination of experience and/or education will be taken into consideration.
• Must possess knowledge of all applicable regulatory agencies that govern the industry.
• Basic knowledge of pharmaceutical laboratory testing practices and manufacturing processes are preferred.
• Must possess expert-level knowledge of Quality investigations, practices, processes, policies, and procedures.
• Must possess excellent leadership skills that encompass visionary, analytical, strategic, critical, and systems thinking skills.
• Strong communicator with the ability to influence others and solve problems through independent judgment and analysis.
• Must demonstrate an exceptional degree of innovation, creativity, and resourcefulness.
• Must demonstrate ability to make key decisions that affect the success of the Quality group and Viatris.
• Must possess computer skills and a working knowledge of Microsoft Office suite.
• Ability to read and interpret complex business and/or technical documents.
• Ability to write comprehensive reports and detailed business correspondence.
• Ability to work with groups of people such as other departments and communicate known concepts.
• Ability to present to a group of departments.
• Ability to perform computations such as percentages, ratios, and rates.
• 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.
• Proficiency in speaking, comprehending, reading, and writing English is required.

Requirements

• Typically sitting at a desk or table; intermittently sitting, standing, walking, or stooping.
• Periodic travel is required.
• May be required to stand; walk; stoop; bend; kneel; and climb steps.
• May require use of hands and arms; sedentary lifting requirements.
• Normal office situation.

Benefits

• Competitive salaries.
• Benefits.
• An inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.

Company Description

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.

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.