QA Technical and Validation Manager

As a Quality Technical and Validation Manager, you will be responsible for overseeing the technical quality assurance and validation activities to ensure compliance with regulatory requirements, industry standards, and GSK policies. You will play a critical role in maintaining the highest levels of product quality and safety.

This role leads a team that has responsibility and accountability for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. This includes overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from and to other supply nodes, and robust change management practices to ensure compliance with process, equipment, and computer system validation lifecycle activities.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

• Lead and manage the QA Technical and Validation team, providing direction, support, and development opportunities.
• Develop, implement, and maintain validation and qualification protocols for equipment, processes, and systems.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) in validation and qualification activities.
• Provide quality oversight and approval of technology transfer activities, including review and approval of process and analytical tech transfer tasks and protocols.
• Review and approve validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Collaborate with cross-functional teams, including Manufacturing, Engineering, and Regulatory Affairs, to ensure successful project execution and compliance.
• Conduct risk assessments and develop mitigation strategies for validation activities.
• Monitor and analyze validation data, identifying trends and areas for improvement.
• Participate in internal and external audits and inspections, providing expertise on validation and quality assurance matters.
• Provide training and guidance to team members and other departments on validation and quality assurance practices.
• Manage and prioritize multiple projects to meet deadlines and deliverables.
• Oversee laboratory business applications, methodologies, and automation to ensure they meet quality and compliance standards.
• Provide computer validation oversight to ensure systems are validated according to regulatory and GSK standards.
• Support PAI and routine regulatory inspections through subject matter expertise as a fronter of topics or a host, as necessary.

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

• Bachelor's degree in Chemistry, Biology, Engineering, or a related field.
• Minimum of 10 years of experience in the pharmaceutical industry.
• Minimum 5 years' combined experience with Process Lifecycle Management, Operational Quality, and analytical equipment and method validation.
• 7 years' prior experience in developing and executing validation protocols for equipment, processes, and systems
• 5 years' Experience managing a high-paced operational or quality-focused team.

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

• Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards for validation and quality assurance.
• Excellent leadership and team management skills, with the ability to motivate and develop team members.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills, with the ability to collaborate across departments and levels of the organization.
• Detail-oriented and highly organized, with the ability to manage multiple projects simultaneously.
• Proficiency in using quality management systems (QMS) and validation software tools.
• GPS training or equivalent preferred.
• Certification in quality assurance or validation (e.g., ASQ, ISPE) preferred.
• Experience with continuous improvement methodologies (e.g., Six Sigma, Lean) preferred.

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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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