Job details
Job type full-time
Full job description
1100 mylan pharmaceuticals inc.
At viatris, we see healthcare not as it is but as it should beWe 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 quality compliance manager role will make an impact:
Key responsibilities for this role include:
Support the approval of simple to medium complex records from the cqn, qas, trackwise and documentum systems.
Evaluate documents needed in support of notifications to health authorities.
Support the regional field alert process.
Pre-assess requirements from government laws and guidelines applicable to usa and europe compliance and quality systems topics.
Participate in different projects carried out at different sites which are key to the business.
Participate in the sites quality council and other metrics forums to escalate key quality systems requiring action plans or resolution strategies.
Support review of sites responses to internal and government audit observations.
Support the regional head role in searching information and tools associated to topics of novel nature requiring preparation of general regional strategies.
Support the project management of strategies to be applied in the region.
Manage requests from the different sites needing special support from other sme groups.
Prepare and track the regional head follow-up system.
Prepare regional weekly to bi-weekly report for continuous communication purposes.
Prepare the na regional budget and participate in the assessment of the different sites budgets and headcount proposal needs.
The minimum qualifications for this role are:
Bachelor’s degree required.
Bs in science (preference bs in engineering) and courses in project management required.
A minimum of 7 years of pharmaceutical industry; preferably in the osd environment with focus in quality and manufacturing operations.
Solid understanding of cgmp’s from usa and europe.
Excellent skills associated to computerized applications and project management.
Knowledge of osd key operations (manufacturing, packaging, engineering, validation, utilities, qc/qa, inspections readiness processes).
Solid understanding of key quality systems (investigations, capa’s, change controls, procedures, specifications).
Excellent computer literate.
Skills associated to processes assessment for improvement and simplification and for determining gaps to established requirements.
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 employerAll 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.
