- 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 Global Quality Master Data Specialist role will make an impact:
Key responsibilities for this role include:
Product Material Identification Codes and associated Master Data for Global APIs, Bulk, Partially Packed and Finished Dosage Forms across the organization per Viatris Change Control Policy.- Oversee and support all IT Projects that impact Global Product Master Data including integrations of Sites and Global Product Master Data into Viatris Global SAP System.
- Perform investigations and support resolution of any GxP issues relating to Global Product Material Master Data and any associated impacted systems involved. This includes supporting Global Quality and local Health Authority inspections relating to SAP and Global Master Data.
- Perform review of Global Supply Chain Bill of Materials in SAP for tolling business models.
- Collaborate with all Global Functions (including Global IT, Global Regulatory Affairs, Global Serialization) and Global Master Data Groups to ensure alignment on data integrity practices and SOPs for compliant data management at Viatris.
- Interact directly with all levels of management as required across the Organization to provide Quality compliance and best practice approach within SAP and the Global Material Master Data program.
- Continue to develop and maintain SOPs relating to Global Master Data Management and perform GMP training for any Groups involved in the creation or editing of GxP impacting Global Product Master Data at Viatris.
- Represent the Global Quality Master Data Group as required and report key information from meetings or issues to Global Quality Master Data Management.
The minimum qualifications for this role are:
A minimum of 5 years Quality/Regulatory experience within a GxP regulated environment is preferred including experience and knowledge of basic GxP requirements across all functions and groups involved in the Global Supply Chain. This includes basic knowledge of Directives and guidelines of major Health Authorities overseeing the manufacture and supply of medicines and devices globally.- Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration
- Knowledge of the Global Viatris Product Portfolio is preferred. Knowledge of Viatris operational Sites and CMOs in the Global Supply Chain is an advantage.
- Must have basic knowledge of the requirements pertaining to Product Specifications, Regulatory Applications and associated Marketing Authorisations. Knowledge of the Regulatory Submissions Process (including variations/filings) is an advantage.
- Basic understanding of Product Uniqueness and Serialization at a global level is an advantage.
- Experience in Quality Systems, data integrity and validation of systems is an advantage.
- Must have a keen sense of attention to detail and the ability to review details and data to make swift assessments and decisions pertaining to quality and/or regulatory impact.
- Must have good communication skills and the ability to escalate and resolve discrepancies or issues with urgency, across multiple Groups and in a collaborative manner.
- Ability to work independently and to your own initiative is a requirement.
- Computer skills with working knowledge of Microsoft Office suite. SAP is desirable but not essential. Proficient skills in Excel are an advantage.
- Experience with SAP and integrations is an advantage.
- An essential part of this role is working with Groups across the entire Viatris Organisation with regards to Global Master Data requirements or dealing with specific issues. An ability to be a team player and work effectively and diplomatically with our colleagues is a skill that is highly valued in this role.
- Proficiency in speaking, comprehending, reading and writing English is required.
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.
