Scientist, Quality Systems

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 …