Senior Manager, Global Quality Digital Systems

Viatris•Torrington, WY

1d•$95,000 - $193,000•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. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here’s how the Senior Manager, Global Quality Digital Systems role will make an impact:

Requirements

Minimum of a Bachelor's degree (or equivalent) in a science-related discipline and minimum of 6 years of directly relevant experience.
Must possess sound knowledge of cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations.
Must be familiar with Global Systems concepts relevant to designated areas.
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.
Must be proficient in leading discussions of complex topics.
Must have computer skills with working knowledge of Microsoft Office.
Proficiency in speaking, comprehending, reading and writing English is required.

Nice To Haves

Master’s degree (or equivalent) preferred.
Minimum of 10 years of relevant experience in Quality and/or Regulatory Affairs, or 8 years of experience with a Master’s degree, preferred.
Quality certifications preferred.
Ability to read and interpret complex business and/or technical documents.
Ability to write comprehensive reports and detailed business correspondence.
Ability to work with managers or directors and communicate ambiguous concepts.
Ability to present to groups across 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.

Responsibilities

Provide support for standardized digital quality systems programs.
Evaluate existing digital quality systems worldwide and perform training of key and required personnel to global policies.
Participate in activities in support of global inspection preparedness, audit response and CAPA related to digital quality systems issues.
Perform independent research of required topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (ICH, GxP etc.).
Provide independent review of departmental and corporate policies and procedures.
Provide interpretation of complex regulations through research of current corporate and governmental expectations.
Facilitate meetings with all levels of Management.
Where required, provide guidance with regard to managing digital quality systems to meet industry, regulatory and corporate expectations.
Review and/or approve system validation documentation including assessment reports, project plans, validation strategy documentation, global quality directives, user requirements, installation qualification, operation qualification, performance qualification, validation summary reports, and change requests under set timelines.
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.