Senior Director, Global Sterility Assurance

BGP Products Operations GmbH 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 a 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 purpose of this critical role is to oversee globally aseptic practices in the steriles manufacturing network, and ensure adherence to evolving expectations from Health Authorities. This role at the Steriles leadership level acts as a senior advisor when it comes to sterile operations strategy. As part of this role, you will create a sterility assurance program and ensure implementation of all aspects of the program in accordance with Viatris regulatory standards and specifically to routine operations, as well as the new product launches and process lifecycle requirements. Working closely with site stakeholders, this position will focus on the sterility assurance culture, operations and awareness to improve the batch success rate and contamination control. Additionally, you will work with the Global Steriles Quality Head, the Site Heads, Site Quality Heads and MSAT Head of Injectables to assure alignment and consistency at the Sterile Vertical level.

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

• Accountable for the compliant, effective and modern contamination control strategy across Sterile Vertical Operations in Viatris.
• Accountable for the implementation of an effective sterility assurance program across Sterile Vertical Operations in Viatris.
• Acts as oversight for Sterility Assurance improvement projects.
• Support stakeholders and specialists to share/create best practices thereby ensuring consistency and effectiveness of contamination control.
• Ensure operational activities are in line with cGMP expectations.
• In consultation with Site and Global stakeholders, maintain and update the aseptic education and awareness training program to ensure aseptic sustainability.
• Provides sterility assurance expertise on facility designs, flows, zone concepts, investigations, and new product introductions/tech transfers to meet global and regulatory requirements from an early stage.
• Continuously performs global review and alignment on best practice.
• Includes: Aseptic behavior, Sterilization, APS, Material controls, Clean room management, Cleaning and Disinfection, Cross contamination, Supplier management for critical suppliers.
• Provides support for preventive and corrective efforts as a result of critical investigations, audit and inspection findings to improve Sterility Assurance.
• Works with global and site QC microbiology (as well as contract testing labs) on Sterility Assurance topics such as sterility test failures and EM excursions.
• Works with the Global Technical Functions and Global Quality reviewing and aligning on best practice in contamination control.
• Perform/Review Contamination Risk Assessments (RA) to harmonize standards across the site and assets to ensure uniformity with the ability to articulate technical aspects of completed RA.
• Support audits and incidents management for external sterile manufacturing partners.

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:

• Strong understanding of USP and EP, endotoxin, and sterility testing is required.
• Comprehensive understanding of the major Regulations and Guidelines pertaining to the pharmaceutical industry. Specifically GMP compliance knowledge including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance.
• Hands-on experience in complex investigations in both preventive and reactive contamination control.
• Knowledge and experience in microbiological test technologies, efficacy studies and recovery methods.
• Strong regulatory understanding of environmental monitoring programs that can enable proactive assessment of controls prior to exceeded action limits.
• Technical knowledge of clean room engineering including particle control mechanisms.

Benefits

At Viatris:

• 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.

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, recognising that our actions affect the stakeholders and communities we serve.

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.