Manager, Global Quality Investigations

Viatris•Torrington, WY

4d•$78,000 - $152,000•Remote

About The Position

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. The Manager, Global Quality Investigations role will perform real-time review of investigations/post-market complaints to determine their robustness, ensure the implementation of appropriate corrective/preventative actions based on appropriate root cause and assessment of impact. This role will also review and participate in investigations associated with critical quality events/escalations and supplier non-compliance/escalations, providing guidance for continuous compliance and quality improvement. The position involves timely reporting of analyzed data through governance and appropriate escalation of critical findings to global and regional quality management. The role also includes performing assessments of Global SOPs/Policies with site SOPs and communicating opportunities for enhancements to sites. The Manager will prepare and present monthly metrics summaries for all key attributes associated with investigations review, routinely interact with all stakeholders at site, regional and global levels, and stay current with industry standards and interpretations of key regulations, applying all applicable learnings in review process enhancements. The role will monitor and respond to key performance indicators from the investigational metrics across the assigned regions/sites in order to mitigate business risk.

Requirements

Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration.
Must possess knowledge of all applicable regulatory agencies that govern the industry.
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 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.

Nice To Haves

Basic knowledge of pharmaceutical laboratory testing practices and manufacturing processes are preferred.
Ability to understand pharmaceutical calculations is preferred.

Responsibilities

Perform real time review of investigations/post market complaints to determine the investigations’ robustness, ensure the implementation of appropriate corrective/preventative actions based on appropriate root cause and assessment of impact.
Review and participate in the investigations associated with the critical quality events/escalations and provide guidance for continuous compliance and quality improvement.
Review and participate in the investigations associated with the supplier non-compliance/escalation and provide 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.
Perform assessment of Global SOPs/ Policies with site SOPs and communicate to sites with opportunities for enhancements.
Prepare and present monthly metrics summary for all key attributes associated with investigations review.
Routinely interact with all stakeholders at site, regional and global levels.
Stay current with industry standards and interpretations of key regulations and apply all applicable learnings in review process enhancements.
Monitor and respond to key performance indicators from the investigational metrics across the assigned regions/sites in order to mitigate business risk.