Senior QC Manager

Rottapharm Limited

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

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

• Day-to-day management of both chemistry and microbiology labs, which includes the release of raw materials, packaging components and finished products to meet the production and shipping schedules as appropriate.
• Ongoing maintenance of the site stability programme.
• Ongoing maintenance of the retain samples programme.
• Liaise with manufacturing to ensure that raw materials, in-process lots and finished products are released in a timely and cost effective manner.
• Ensure that all laboratory personnel are trained in their appropriate duties in GMP and GLP through a defined structure programme and that training records are updated on an ongoing basis.
• Responsible to recruit and develop training plans as well as personnel development plans for all laboratory personnel.
• Assist in the preparation for internal and external audits by regulatory bodies.
• Carry out performance appraisals for QC laboratory personnel.
• Ensure analysis and approval of all validation data in a timely manner and approval of validation documentation as required.
• Ensure validation of test methods and method transfers are executed and documented as required.
• Responsible for the safety of all laboratory personnel and notification of any safety concerns to Quality Director/EHS Advisor.
• Responsible for the coordination and performance of the continuous improvement programme within the quality control laboratories.
• Financial management of resources and expenses of the Quality control function within budget agreed.

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 in a relevant field, such as pharmacy, chemistry, biology or a related discipline.
• Advanced degrees (Master's or Ph.D.) may be an advantage.
• 5-7 years of leadership experience in quality control laboratory (chemistry/microbiological) activities or a related area within the pharmaceutical industry with a focus on compliance with GMP and GLP.
• A minimum of 5 years of people management experience.
• In-depth knowledge of relevant applicable regulations and guidelines such as EMA, ICH, EP and other global regulatory requirements.
• Experience in interacting and facilitating HA inspections and audits
• Strong technical writing 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.