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
Senior QA Manager will support Senior Quality Leadership by providing systematic overview of the sites compliance and state of control through management of the site self-inspection program and by providing support to the site incident report (CAPA) system. The role requires an active partnership with the Senior Quality Assurance Manager & relevant Compliance leads in transforming the site quality system to support the site to ensure that high standards of GMP are maintained at all times The role 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 Operations Manager role will make an impact:
- Manage the site compliance and quality systems.
- Manage the day to management of Quality Management System in compliance in line with GMP and appropriate global and site policies and procedures, such as Complaints, CAPA, Deviations and Change Control and global improvement programs for product Quality.
- 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.
- Manage training program to cater for quality oversight to ensure a robust compliance framework.
- Attract, retain and proactively develop a pipeline of key talent in the Quality Assurance Organization through coaching, training, experience development and internal/external recruitment.
- Management of the Quality Risk Management process per the requirements of ISO 14971:2019 Assist with the departmental budget process and ensure periodic reviews are completed for continuity.
- Responsible for establishing the site GEMBA process inline with the changing infrastructure requirements.
- Demonstrate commitment to high standards of GMP compliance and product quality.
- Interface with site operation owners to collect and analyze key data related to Quality Metrics as required.
- 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 KPI’s., whilst ensuring team well-being is monitored and managed.
- Assist & coordinate for site Inspection Readiness including the preparation, handling and responding to quality system audits of the site by regulatory authorities, corporate auditors or customers. Perform other duties as assigned to adapt to changing needs of the business.
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 or engineering related discipline and a minimum of 10 years relevant experience within a sterile manufacturing facility at management level or an MSc / MEng degree (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
- Must possess extensive knowledge of Pharmaceutical, Combination Product Process Quality. Use of Lean principals desirable.
- 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
- 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 organizational 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 Product Quality
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.
Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
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.
