Senior QA Systems Manager

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 Senior Quality Assurance (QA) Manager has responsibility for administration of the Quality Management System at Mylan Teoranta (A Viatris Company), with responsibility to ensure products are manufactured according to all applicable regulatory and corporate guidelines. The Senior QA Manager is responsible for the day to day management of the QA department, identified as the Management representative per the requirements of ISO 13485: 2016; reports directly to the Senior Director QA and where relevant is the nominated designate.

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

• Responsible for the overall management and administration of the Quality Assurance Department.

• Responsible for the overall administration of the Quality Management System (QMS) at Mylan Teoranta.

• Responsible for the management and engagement of all Team Leads within QA.

• Responsible for site Inspection Readiness including the preparation, handling and responding to quality system audits of the site by regulatory authorities, corporate auditors or customers.

• Responsible for the management of the site Complaint Handling process, site Document Control process, Vendor Management process.

• Responsible for the management and implementation of the relevant impact assessments for the purpose of assessing New & Revised Standards.

• Responsible for management of the of the site Change Control cprocess (both temporary and permanent changes).

• Responsible for management of the site Deviation management / Non-Conformance (Incident Report) & CAPA process.

• Support new product introduction to the site and new product launches as required ensuring the QMS processes are considered and can cater for quality oversight to ensure a robust compliance framework.

• Provide Quality leadership and technical guidance as required to all personnel at the site. Drive a culture that ensures quality and continuous improvement is central with positive impact on site KPIs, whilst ensuring team well-being in monitored and managed.

• Demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable quality outcomes.

• Stay abreast of changing requirements/expectations and proactively address within the quality system. Implement appropriate solutions that address complex technical, legal and global regulatory standards.

• Allocate resources based on the quality system priorities and corresponding business needs. Establish high standards for performance management and accountability to achieve quality and organizational objectives. Assign project work and review workload for all direct reports. Assist staff with their responsibilities establishing goals and set objectives that will increase their knowledge and skills level.

• Assist with the departmental budget process and ensure periodic reviews are completed for continuity.

•  Attract, retain and proactively develop a pipeline of key talent in the Quality Assurance Organization through coaching, training, experience development and internal/external recruitment.

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 a science or engineering related discipline and a minimum of 10 years relevant experience within a sterile manufacturing facility at management level or an MSc degree /MEng (or equivalent ) in a related discipline and a minimum of 5-10 years relevant experience within a sterile pharmaceutical manufacturing facility and / or Medical Device, Combination Product manufacturing.

• Experience of all quality system aspects in relation to sterile pharmaceutical/medical device manufacturing, including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification.

• Good working knowledge of applicable standards and regulations for sterile manufacturing, including but not limited to Annex 1, ICH210, 211, 21 CFR 820, Part 4 & Part 11 Compliance.

• Must possess extensive exposure to Health Authority (FDA, HPRA, etc) and Notified Bodies (DEKRA, NSAI, etc).

• Excellent communication (both oral & written), interpersonal and presentation skills with a hands-on approach to team leadership.

• Demonstrated strong people management skills.

• Candidates should be self-motivated with the ability to work on their own initiative and should possess excellent organisational and time management skills with the ability to handle multiple tasks in a fast-paced environment.

• Candidates should demonstrate innovative capacity and out of box thinking abilities and be able to apply lean / 6-Sigma practices within the QMS.

• Candidates must be comfortable with reporting to Key Stakeholders at and above site at Global level.

• It is highly desirable that the incumbent is an SME is CAPA & Critical Investigations for Quality Systems.

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.