QA Manager (QAA Affiliates)

Mylan Teoranta

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. 
 

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Quality Assurance Manager (QAA Affiliates) will be responsible for the quality management of contract manufacturing operations providing Mylan injectable products, ophthalmic products and medical devices to the US Market. The role will provide systematic overview of third party manufacturing operations to ensure compliance and state of control through frequent and extensive on-site & off site assessment, and leading corrective & preventive action plans as needed in response to quality indicators to ensure a continuous state of GxP compliance

Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Manager (QAA Affiliates) role will make an impact:

• Management of the third party quality team who are responsible for quality oversight of third party manufacturer, packaging, laboratories and distribution sites.

• Main area of responsibility will be to:
  - Maintenance of Quality Management Systems, ensuring compliance to GxP and Global policies.
  - Management of Batch Records Review and Release of Finished Product into the US markets.
  - Manage the oversight of Manufacturing Investigation of Finished Product into the US Markets and other Markets as required.
  - Act as Responsible Person (RP) ensuring compliance in Good Distribution Practice of medicinal products in EU.Work  as quality lead providing support as required (Affiliate - US market) during product development, technology transfer transfers and product launches for third party operations.

• Work  as quality lead providing support as required (Affiliate - US market) during product development, technology transfer transfers and product launches for third party operations - Oversight of change control & complaints for the US Market.

• Provide support to the third party quality operations team in the following areas;
  - Oversight of change control & complaints for the US Market
  - Prepare/Review/Submit Initial FARs, Follow Up FARs and Final FARs  if required (Injectable  - US market)
  - Prepare/Review/Submit Recall Documentation for Injectables  - US market;
  - Coordinate with Viatris Recall Coordinator and FDA Recall Coordinator as required
  - Annual Reports, Annual Product Quality Reports, Stability Program for US market
  - Vendor Management

• Work with the third party manufacturing Quality teams to ensure policies are implemented and procedures are followed to ensure compliance with all applicable guidelines, cGMPs, SOPs, and Mylan policies and procedures.

• Conduct gap analyses and risk assessments of third party operations as required, as needed in order to ensure successful regulatory inspections.

• Assist direct reports with their responsibilities establishing goals that will increase their knowledge and skills level.

• Provide QA technical support in R&D new product introduction projects.

• Perform other duties as assigned.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelor's degree (or equivalent) in the fields of pharmaceutical sciences/engineering, chemistry, biology or related health sciences and 8+ years of practical experience in the pharmac