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Senior Manager, North America 3Rd Party Quality

Company

Viatris
Address , Remote
Employment type FULL_TIME
Salary $95,000 - $193,000 a year
Expires 2023-10-06
Posted at 9 months ago
Job Description
1100 Mylan Pharmaceuticals Inc.
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:
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • 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 Senior Manager, North America 3rd Party Quality role will make an impact:
Key responsibilities for this role include:
  • Effectively manage the completion of laboratory, manufacturing and quality complaint investigations reviews, along with any associated trends for adequacy of root cause analyses, appropriate impact assessment, justifiable and compliant product disposition, and associated corrective and preventive actions.
  • Foster continuous process improvements of these critical quality systems throughout all impacted stakeholders.
  • Where required, assist in the development, deployment and management of IT platform solutions to meet industry, regulatory and corporate expectations.
  • Stay up to date of current industry and regulatory standards, including FDA, EMEA, MHRA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations (ICH, GxP etc) including assessment of applicability and impact on systems.
  • Review and effectively manage/direct the completion of 3rd party Change Controls, Labeling & Artwork and APR/PQRs, along with various GMP documents for product review and release, as well as for regulatory filings for adequacy of documentation, appropriate impact assessments, and for justifiable and compliant product disposition/release.
  • Directly manage communication with internal and external quality staff and participate in meetings/calls with all levels of internal and external management and leadership.
  • Develop, initiate, or propose modifications to the current training program(s) to ensure all processes and staff are in alignment with current industry and regulatory standards.
  • Perform and troubleshoot critical product quality and investigative trends.
  • Escalate critical findings to senior quality leadership and collaborate with sites, regional and vertical quality and operations leadership to address critical quality issues and potential impact.
  • Maintain metrics pertaining to the team’s Quality processes (at a minimum) and communicate these metrics to the appropriate groups as dictated by regional or global quality policy.
The minimum qualifications for this role are:
  • Travel may be required.
  • 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.
  • Industrial plants and their environments.
  • Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
  • None required. Quality certifications preferred.
  • Proficiency in speaking, comprehending, reading, and writing English is preferred.
  • Must possess strong communication and written skills. Excellent organizational and deductive reasoning skills are essential in job performance. Familiarity with various local and international health authority regulations and cGMP requirements are a must. Must be proficient with Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Outlook. Must be able to access information via the Mylan network and retrieve the necessary data. Familiarity with SAP, TrackwiseTM and LIMS is preferred. Familiarity with Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control environments is a plus. Must be able to work and interact well with other employees at all levels.
  • Minimum of a Bachelor's degree (or equivalent) in a science related discipline and minimum of 6 years of experience in an analytical, quality, or manufacturing environment. A Master’s degree (or equivalent) and minimum of 10 years relevant experience in Quality and/or Regulatory Affairs preferred. However, a combination of experience and/or education will be taken into consideration.
  • 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 use of arms. Sedentary lifting requirements.
  • Normal office situation.
  • Position functions autonomously and can involve direct supervisory requirements, 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.
  • 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.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 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.
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