Senior Director, Global Sterility Assurance

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Company Overview

Viatris is a global healthcare company dedicated to bridging the traditional divide between generics and brands. Established through the merger of Mylan and Upjohn (a division of Pfizer), Viatris is positioned to meet healthcare needs worldwide. The company focuses on empowering people to live healthier lives, providing access to high-quality medicines for approximately 1 billion patients around the globe each year. Viatris offers a comprehensive portfolio including both iconic brand-name products and a diverse array of generics in various therapeutic areas.

Role Overview

The Senior Director of Global Sterility Assurance role aims to oversee aseptic practices within sterile manufacturing networks. This critical position emphasizes adherence to evolving standards set by health authorities and ultimately contributes to enhancing patient safety and product quality. Working closely with global leaders, the Director will foster a culture of sterility assurance that supports operational effectiveness and compliance.

Responsibilities

In this role, the Senior Director will be accountable for:

1. Developing and executing the sterility assurance program across operations, including routine activities, new product launches, and changes in process lifecycle requirements.
2. Fostering a sterility assurance culture, improving batch success rates, and implementing effective contamination control strategies across Sterile Vertical Operations.
3. Ensuring operational activities comply with current GMP expectations.
4. Coordinating with global and site stakeholders to enhance aseptic education programs, ensuring sustainability in practices across all facilities.
5. Providing technical expertise for facility designs, investigations, and new product introductions that align with global regulatory standards.
6. Performing risk assessments and leading the incident management processes related to sterile manufacturing.

Required Skills and Experience

Candidates vying for the Senior Director position should possess:

• A strong understanding of United States Pharmacopeia (USP) and European Pharmacopeia (EP), regulatory requirements, and compliance guidelines comprising GMP, ISO, and FDA standards.
• Significant hands-on experience in tackling complex contamination issues in both preventive and reactive scenarios.
• Knowledge of microbiological test technologies and environmental monitoring programs that effectively predict and mitigate contamination risks.
• Proficiency in clean room engineering focusing on contamination and particle control.

The ideal candidate will also showcase leadership abilities, a proven track record in pharmaceutical manufacturing, regulation compliance, and a commitment to driving advancements in quality assurance practices.

Salary and Benefits

While specific salary figures were not disclosed in the job listing, Viatris advertises competitive compensation packages and a bonus scheme as part of their employment offerings. Beyond salary, the company provides a range of benefits, including health insurance, retirement plans, and personal development opportunities. Noteworthy aspects of Viatris’ benefits package include:

• Competitive salary packages with performance-based bonuses.
• Health and wellness programs including health insurance and counseling services.
• Pension plans for retirement and financial security.
• Strong focus on career growth and progression opportunities.

Work Environment and Corporate Culture

Viatris advocates for a culture of inclusion and diversity, valuing the unique experiences and perspectives of its employees. The company underscores the importance of corporate social responsibility, sustainability, and ethical practices. Employees are encouraged to engage in community outreach and initiatives aimed at improving healthcare outcomes worldwide.

Conclusion

The Senior Director of Global Sterility Assurance role at Viatris presents a significant opportunity for experienced professionals interested in the pharmaceutical manufacturing sector. With a strong commitment to compliance and quality assurance in sterile operations, this position plays a crucial role in enhancing public health through safe and effective medication delivery. That's why professionals looking for a role where they can leverage their knowledge and drive organizational change should consider applying for this position.

This job offer was originally published on himalayas.app