Global SME Analytical Validation & Lifecycle

工作内容

Be You’ at GSK

At GSK, we’re a company with a purpose to help people do more, feel better and live longer.We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. Theseare at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal.You commit to living our values and expectations and performing against our Innovation, Performance and Trustpriorities. In return, GSK commits to providing the right environment for you to thrive.Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively

Global SME Analytical Validation & Lifecycle

Do you want to make a difference? Are you energised by global quality and close partnership and collaboration with key stakeholders, bringing the quality mindset? If so, this opportunity to join a diverse team of experts could be the perfect fit for your career.

We are looking to recruit a Global Subject Matter Expert (GSME) Analytical Validation and Lifecycle. This role is part of the GSME team within global quality (GQCPQ), whose mission is to anticipate the future and drive competitive advantage, impact internal change and shape external environment, while unleashing the power of the network by driving continuous learning and engagement.

Your Responsibilities

Key Responsibilities include, but are not limited to:

Technical Expertise & Knowledge

• Establish and maintain current knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence and industry standards
• Define GSK vaccine requirements which are implemented to ensure compliance
• Support site in implementation of GSK Vaccine requirements and monitor site implementation status
• Provide expertise support (e.g. inspections preparation and response writing, observations, deviations, improvement initiatives, remediation)
• Drive continuous improvement and simplification activities of systems & processes, with application of risk management principles and tools.
• Support the implementation of new technologies and analytical approaches in the QC network of laboratories through proposing validation approaches but also through the adaptation of GSK Vaccines analytical method validation framework.
  

Strategic Direction

• Set global vaccines vision and strategy in collaboration with key stakeholders within network bringing forward new innovative ideas for improvements in analytical method practices.
• Drive and deploy and monitor Digital & Data Analytics innovation projects within QC of the Future program
• Identify and implement opportunities for alignment of processes transversally
  

Network Interaction

• Lead a network of local experts and develop, deliver and organize training, building capability in QC network to support deployment of analytical lifecycle programs and ensure continued compliance.
• Apply knowledge management to ensure harmonization and use of best practices across products, processes and sites.
  

External Advocacy

• Monitor and assess new developments, industry trends, evolving regulatory expectations
• Influence the external environment to drive advocacy strategy through representation of GSK in external boards and ensure the deployment of new standards within GSK
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• University degree Pharmaceutical Sciences, Microbiology, Chemistry, Bio/Chemical Engineering
• At least 10 years of experience in pharma/vaccines/healthcare industry
• Strong technical expertise & understanding of QC processes & ability to interact efficiently and influence QC experts
• Quality mindset with good knowledge of pharmaceutical operations (including manufacturing and testing of vaccines) and quality systems
• Proven ability to manage networks and build relationships transversally across networks through excellent communication and engagement skills
  

Preferred Qualifications And Experience

If you have the following characteristics it would be a plus:

• Ability to adapt, work under uncertainty and accommodate flexible work demands.
• Passion for improvements and innovation and ability to develop new business processes and guide their successful deployment.
• Strategic thinking and demonstrate enterprise thinking, understanding the “Big Picture” with business acumen
• Ability to interact authoritatively with and challenge internal and external stakeholders on a range of technical subjects, and willingness to travel abroad if & when needed (around 10%)
• Familiarity with project management & result-oriented and proactive work style
• Ability to handle multiple issues and effectively prioritize, working in a liquid organisation and agile environment.
  

This role is based at Belgium but all other locations will be considered on a case by case basis.

• Li-GSK
  

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Why GSK?:

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our Department

Vaccines Global Qualityis responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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