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.

 Why you?

Basic Qualifications:

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.

Preferred Qualifications:

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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