Scientist, Quality Systems

Mylan 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: 

• Access – Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 

• 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 Scientist, Quality Systems role will make an impact:

Key responsibilities for this role include:

• Foster continuous improvements in system practices throughout the corporation to meet/exceed global regulatory requirements.

• Perform independent research of topics and FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, and other national, international, or supranational regulations/guidance’s (e.g., GxP, ICH, etc.) including assessment of applicability and impact on systems.

• Evaluate, implement, and execute systems for standardizing compliant practices.

• Monitor regulatory trends and identify industry “best practices” for required quality system topics. Increase compliance through identification, development, and implementation of global quality policies/guidelines and procedures.

• Perform on-site and TEAMs training of key personnel.

• Review site SOPs to ensure alignment with global policies and procedures.

• Review site protocols, reports, risk assessments, etc. to ensure compliance with global policy and government regulations.

• Support resolution of technical quality issues of an analytical nature.

• Participate in activities in support of global inspection preparedness, audit response, and CAPAs related to global systems issues.

• Where required, develop, deploy, and manage IT platform solutions (e.g., cleaning validation software) to meet industry, regulatory, and corporate expectations.

• Conduct purpose driven meetings with site SMEs to facilitate alignment with global policy. Meetings should be risk based, agenda driven, and drive closure of any identified gaps in practice.

• Assist in developing health-based metrics for the cleaning validation program. Facilitate collection of data to support said metrics on a monthly/quarterly basis.

• Position requires international travel 30%.

• Perform other duties as assigned.

The minimum qualifications for this role are:

• Minimum of a Bachelor’s degree (or equivalent) and 4-7 years of experience in a science/engineering related discipline. A Master’s degree (or equivalent) and 2 years of experience. A Ph.D. and 0-2 years of experience preferred. 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 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. Ability to work with managers or directors and communicate ambiguous concepts. Ability to present to groups across the organization.

• Position reports to the Senior Manager of Global Quality Systems. Position functions semi-autonomously.

• Ability to write comprehensive reports and detailed business correspondence.  Ability to read and interpret complex business and/or technical documents. Ability to work with managers or directors and communicate ambiguous concepts.  Ability to develop and present detailed scientific information to groups internal and external to the organization including industry peers.

• Ability to perform advanced computations such as algebra, trigonometry and calculus, as well as perform statistical analysis. Ability to draw and interpret graphical data. Ability to understand pharmaceutical calculations is required.

• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.  Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

• Lifting, sitting, standing, walking or stooping may be required.  Long periods at a computer will be required.  Periodic to frequent travel is required.

• Remote position with required travel to sites.

• Proficiency in speaking, comprehending, reading, and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $66,000 - $127,000.

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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