QA Manager (QAA Affiliates)

at  Viatris

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 Quality Assurance Manager (QAA Affiliates) will be responsible for the quality management of contract manufacturing operations providing Mylan injectable products, ophthalmic products and medical devices to the US Market. The role will provide systematic overview of third party manufacturing operations to ensure compliance and state of control through frequent and extensive on-site & off site assessment, and leading corrective & preventive action plans as needed in response to quality indicators to ensure a continuous state of GxP compliance

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

• Management of the third party quality team who are responsible for quality oversight of third party manufacturer, packaging, laboratories and distribution sites.
• Main area of responsibility will be to:
• Maintenance of Quality Management Systems, ensuring compliance to GxP and Global policies.
• Management of Batch Records Review and Release of Finished Product into the US markets.

• Manage the oversight of Manufacturing Investigation of Finished Product into the US Markets and other Markets as required.

• Act as Responsible Person (RP) ensuring compliance in Good Distribution Practice of medicinal products in EU.Work as quality lead providing support as required (Affiliate - US market) during product development, technology transfer transfers and product launches for third party operations.

• Work as quality lead providing support as required (Affiliate - US market) during product development, technology transfer transfers and product launches for third party operations - Oversight of change control & complaints for the US Market.

• Provide support to the third party quality operations team in the following areas;

• Oversight of change control & complaints for the US Market

• Prepare/Review/Submit Initial FARs, Follow Up FARs and Final FARs if required (Injectable - US market)

• Prepare/Review/Submit Recall Documentation for Injectables - US market;

• Coordinate with Viatris Recall Coordinator and FDA Recall Coordinator as required

• Annual Reports, Annual Product Quality Reports, Stability Program for US market
• Vendor Management
• Work with the third party manufacturing Quality teams to ensure policies are implemented and procedures are followed to ensure compliance with all applicable guidelines, cGMPs, SOPs, and Mylan policies and procedures.
• Conduct gap analyses and risk assessments of third party operations as required, as needed in order to ensure successful regulatory inspections.
• Assist direct reports with their responsibilities establishing goals that will increase their knowledge and skills level.
• Provide QA technical support in R&D new product introduction projects.
• Perform other duties as assigned.

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 the fields of pharmaceutical sciences/engineering, chemistry, biology or related health sciences and 8+ years of practical experience in the pharmaceutical or biologics industry is required.
• Proven ability to lead teams through resolution of complex quality or compliance issues. Direct experience in US and European regulatory inspections management. Technical writing experience with emphasis in manufacturing and quality aspects of pharmaceutical investigations/deviations; providing consultation and direction regarding Quality and Manufacturing investigational pathways. (A combination of experience and/or education will be taken into consideration.)
• Extensive knowledge of all applicable pharmaceutical regulations that govern the industry. Must possess extensive knowledge of Quality best practices, processes and procedures and sound technical understanding of pharmaceutical systems and equipment.
• 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 essential.
• Knowledge of Quality Risk Management Systems;
• Experience in Trackwise & SAP
• Knowledge of cGMPS i.e., USFDA,
• Must possess leadership skills that encompass visionary, analytical, strategic, critical and systems thinking skills. Strong communicator with the ability to influence others and solve problems through independent judgment and analysis. Must demonstrate an exceptional degree of innovation, creativity, and resourcefulness. Must demonstrate ability to make key decisions that affect the success of the Quality group and Mylan.
• Must possess:
• Excellent communication (verbal and written) and interpersonal skills
• Excellent presentation skills
• Promote a strong personality with positive attitude
• Self-starter with demonstrated efficient and effective work methods and strong initiative
• Demonstrated people management skills
• Hands on approach to team leadership
• Approachable
• Candidates should be self-motivated with the ability to work on their own
• Possess excellent organizational and time management skills

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.

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

• Management of the third party quality team who are responsible for quality oversight of third party manufacturer, packaging, laboratories and distribution sites.
• Main area of responsibility will be to:
• Maintenance of Quality Management Systems, ensuring compliance to GxP and Global policies.
• Management of Batch Records Review and Release of Finished Product into the US markets.
• Manage the oversight of Manufacturing Investigation of Finished Product into the US Markets and other Markets as required

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 the fields of pharmaceutical sciences/engineering, chemistry, biology or related health sciences and 8+ years of practical experience in the pharmaceutical or biologics industry is required.
• Proven ability to lead teams through resolution of complex quality or compliance issues. Direct experience in US and European regulatory inspections management. Technical writing experience with emphasis in manufacturing and quality aspects of pharmaceutical investigations/deviations; providing consultation and direction regarding Quality and Manufacturing investigational pathways. (A combination of experience and/or education will be taken into consideration.)
• Extensive knowledge of all applicable pharmaceutical regulations that govern the industry. Must possess extensive knowledge of Quality best practices, processes and procedures and sound technical understanding of pharmaceutical systems and equipment.
• 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 essential.
• Knowledge of Quality Risk Management Systems;
• Experience in Trackwise & SAP
• Knowledge of cGMPS i.e., USFDA,
• Must possess leadership skills that encompass visionary, analytical, strategic, critical and systems thinking skills. Strong communicator with the ability to influence others and solve problems through independent judgment and analysis. Must demonstrate an exceptional degree of innovation, creativity, and resourcefulness. Must demonstrate ability to make key decisions that affect the success of the Quality group and Mylan.
• Must possess:
• Excellent communication (verbal and written) and interpersonal skills
• Excellent presentation skills
• Promote a strong personality with positive attitude
• Self-starter with demonstrated efficient and effective work methods and strong initiative
• Demonstrated people management skills
• Hands on approach to team leadership
• Approachable
• Candidates should be self-motivated with the ability to work on their own
• Possess excellent organizational and time management skill