Senior QA Executive - Quality Compliance

Viatris 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.

We have been included on number of award lists that demonstrate the impact we are making.
 

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 Senior Quality Assurance Executive is responsible for providing Quality, Regulatory Compliance and Technical oversight Mylan Affiliate organizations contracted to develop, manufacture, release and / or supply sterile and / or injectable product.

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Executive role will make an impact:

• Manage core competencies activities of the team.

• Support in management of Quality Management system oversight, including review and approval of Complaints, Escalations, FAR,  Investigations, OOS, and CAPAs where required.

• Collaboration and presentation of vertical management review.

• Manage and support the Internal Audit Programme.

• Support on site Health Authority Inspections when required.

• SOP review for compliance to Guidance and Global Policy and maintaining the revision on GMP documentation within the team.

• Act as Quality Subject Matter expert in Quality System activities where required, for example in Trackwise, Documentum, Legal Contract Management (LCM).

• Support Head of Global Quality in continuous improvement programme for the Mylan Injectable vertical.

• Perform gap assessments, inspect and review the facility, equipment, processes, methods, protocols and reports of Affiliate site processes for efficiency and compliance.

• Mentor the Injectable sites in Training in areas identified for development needs.

• Leading process improvement projects where required.

• Train and mentor junior member in the team.

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:

• Bachelor’s degree (or equivalent) in a Science related discipline with some years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department is essential.

• Previous experience of leading a team of Quality Assurance Executives is essential.

• Experience of sterile injectable manufacturing and third party/affiliate site quality management desirable but not essential.

• Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, and batch release.

• Knowledge of Validation and Aseptic manufacturing an advantage but not essential.

• Knowledge of Pharmaceutical QMS Systems, Quality Risk Management Systems, cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.

• Excellent organization, communication (verbal and written), interpersonal and presentation skills

• Computer skills i.e., Microsoft Office, Windows etc. Experience in Trackwise, LIMS & SAP would be advantage

• Self-starter with demonstrated efficient and effective work methods and strong initiative

• Promote strong personality with positive attitude and approachable

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

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

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.