Senior Quality Assurance Specialist

Viatris Inc. (NASDAQ: VTRS) 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.

With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris.

We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.

Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

Benefits at Viatris

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.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion.

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.

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 Senior Quality Assurance Specialist role will make an impact.

Role Purpose:

Reporting to the Quality Assurance Manager (Compliance), the role of the QA Specialist / Senior

QA Specialist (Compliance) is to drive quality culture and promote GMP compliance to site,

collaborate with cross functional subject matter expert (SME) to improve quality system,

understand regulatory expectations and support site inspection readiness, provide quality

oversight to supplier management to ensure purchased material meet specification, collaborate

with GCMC to support regulatory filing activities and addressing board of health queries.

Key responsibilities for this role include, but not limited to:

• Review and approve GMP documentation and ensure site compliance with Corporate Policy

and Standard Operating Procedure (SOPs). Ensure site adherence to quality procedures,

regulatory requirements and current Good Manufacturing Practices (cGMP).

• Ensure accurate reporting of site quality metrics and facilitate management review to

proactively identify trends and atypical observations.

• Conduct internal audits to ensure site compliance to Viatris Quality Policies and applicable

regulatory requirement.

• Maintain site inspection readiness. Support site inspections readiness activities and logistic

during regulatory inspection, customer audit and corporate audit. Support written response to

Board of Health (BoH) within expected due date when required.

• Qualify and manage suppliers during the lifecycle according to SOPs and maintain accurate

records of supplier status. Review quality related issues and investigation from suppliers and

ensure remediation action plan is adequate to mitigate compliance risk.

• Establish quality agreement with supplier and maintain the quality agreement throughout its

lifecycle.

• Conduct supplier audit as required to ensure supplier conforms to Viatris global policies and

applicable regulatory requirement.

• Collaborate with site Training department to conduct annual cGMP training.
• Collaborate with GCMC to support regulatory filing activities. Coordinate with site SME to

address queries from BoH accurately and timely. Track regulatory commitment to ensure

completion within committed timeline.

Qualification

• Degree or Diploma in Science or Pharmaceutical/ Chemical Engineering

Skills and Experience

Some of the key competencies required:

• Proficient in Microsoft Office applications, including Excel, Word, PowerPoint, Outlook,

and Teams.

• Preferred experience with Electronic Quality Management Systems for management of

deviations, CAPAs, change controls, document management, and training records.

• Ability to analyze and trend quality data using spreadsheets and reporting tools.
• Effective collaboration and ability to work in a cross-functional global environment.
• Strong analytical, problem-solving, and risk assessment capabilities.
• Strong attention to detail and organizational skills.
• Ability to influence and negotiate with internal and external stakeholders.
• Demonstrated integrity, sound judgment, and commitment to quality and compliance.
• Ability to manage multiple priorities and deliver results in a dynamic environment.
• Adaptability and continuous learning mindset.

Additional qualifications include:

• Senior QA Specialist: Degree holder with a minimum of 3 years experience in Quality

Assurance role within the pharmaceutical industry or Diploma holder with minimum of 5 years

experience in Quality Assurance role within pharmaceutical industry.

• QA Specialist: Degree Holder with a minimum of 1 year experience in pharmaceutical

industry or related industry or Diploma holder with a minimum of 3 years experience in

pharmaceutical industry.