Sterility Assurance Senior Expert

## Opportunity Spotlight: Sterility Assurance Facility Manager at GSK Barnard Castle This review offers potential candidates a comprehensive overview of the Sterility Assurance Facility Manager role at GSK's Barnard Castle site, highlighting its unique advantages and key considerations for career growth.

GSK's Barnard Castle site stands as a critical secondary manufacturing hub, boasting significant investment in cutting-edge Industry 4.0 technology. This commitment to innovation supports the introduction of new products and increased production volumes, contributing approximately ~$2 billion in annual revenue. GSK fosters an environment where employees can thrive, emphasizing growth, safety, inclusion, and a welcoming atmosphere. The company offers a competitive remuneration package, including a performance-based annual bonus, comprehensive healthcare and wellbeing programs, a pension plan, and a shares and savings scheme. Embracing modern work practices, the 'Performance with Choice' program provides a hybrid working model, empowering individuals to achieve an optimal work-life balance.

What the Role Entails:

As the Sterility Assurance Facility Manager, you will play a pivotal role in safeguarding product integrity and patient safety. This leadership position involves:

• Spearheading sterility assurance projects to ensure effective implementation of contamination control strategies (CCS) aligned with site objectives and regulatory mandates.
• Providing comprehensive oversight of facility operations, guaranteeing adherence to sterility assurance standards and robust contamination control measures.
• Driving the implementation of site-wide sterility assurance programs through collaboration with cross-functional and above-site teams, ensuring consistency and efficacy.
• Maintaining and operating facilities in accordance with industry best practices, regulatory requirements, and contamination prevention principles.
• Partnering with operations and quality teams to seamlessly integrate contamination control measures into manufacturing processes.
• Monitoring key performance indicators for facility operations and contamination control, identifying opportunities for improvement and implementing corrective actions.
• Serving as the primary point of contact for sterility assurance within facilities, representing the team during critical audits and inspections.
• Contributing to the harmonization and continuous improvement of sterility assurance practices across the organization through knowledge sharing.
• Developing and delivering essential training programs to ensure staff proficiency in sterility assurance and contamination control.
• Supporting strategic planning and execution of facility upgrades to enhance contamination control systems and ensure ongoing regulatory compliance.

Advantages for Your Career Path:

This role presents a compelling opportunity for professionals looking to advance their careers in a dynamic and technologically advanced pharmaceutical manufacturing environment. Key advantages include:

• Impactful Leadership: Lead critical projects and drive significant improvements in contamination control, directly impacting product quality and patient safety on a global scale.
• Technological Exposure: Work with state-of-the-art, bespoke Industry 4.0 equipment, offering hands-on experience with advanced manufacturing technologies.
• Strategic Contribution: Influence site-wide sterility assurance strategies and contribute to the continuous improvement of practices within a leading biopharmaceutical company.
• Cross-Functional Collaboration: Engage with diverse teams across operations, quality, and global functions, broadening your professional network and expertise.
• Career Development: GSK's commitment to employee growth, coupled with the complexity and scale of operations at Barnard Castle, provides ample opportunities for skill development and career progression.
• Work-Life Integration: The 'Performance with Choice' hybrid working model offers flexibility, allowing you to tailor your work environment for optimal productivity and personal well-being.
• Comprehensive Benefits: Access to competitive salary, annual bonus, health and well-being programs, pension, and shares and savings schemes underscores GSK's dedication to employee welfare.

Key Considerations for Candidates:

To excel in this role and maximize its career benefits, prospective candidates should consider the following:

• Foundational Expertise: A Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field is essential, providing the scientific bedrock for understanding sterility assurance principles.
• Proven Sterility Assurance Experience: Significant practical experience in sterility assurance within the pharmaceutical, biotechnology, or a closely related industry is crucial for navigating the complexities of this role.
• Regulatory Acumen: A strong command of regulatory requirements (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO) related to sterility assurance and sterile manufacturing is paramount.
• Problem-Solving and Detail Orientation: The nature of sterility assurance demands exceptional problem-solving skills and an unwavering attention to detail to identify and mitigate risks effectively.
• Leadership and Project Management: Demonstrated ability to lead teams, manage complex projects, and drive initiatives to completion is a core requirement.
• Communication Prowess: Effective interpersonal and communication skills are vital for collaborating with diverse stakeholders and representing the team during critical engagements.
• Strategic Thinking: The ability to contribute to strategic planning and support facility upgrades highlights the importance of forward-thinking and a proactive approach.
• Continuous Learning: An interest in staying abreast of evolving industry best practices and regulatory changes within sterility assurance will be highly beneficial.

For those with a passion for scientific rigor, a commitment to quality, and a desire to contribute to a world-leading biopharmaceutical company, the Sterility Assurance Facility Manager position at GSK Barnard Castle represents an exceptional opportunity to make a tangible difference in healthcare.