Quality Technical and Validation Manager

Position Summary

This role has responsibility and accountability for:

• Ensuring that the facilities, equipment, systems, and processes used in the manufacture and testing of Pharmaceuticals have been appropriately validated and maintained in a validated state.
• Organizing and directing all validation activities including capital projects.
• Working with operations, requiring technical service support for process, product, facilities, and cleaning validation, change control, and continued verification which are essential for GMP and regulatory compliance and continuous improvement objectives.
• Ensuring robust and compliant validation and change control efforts.
• Provide leadership and direction to enable the site to meet its business goals by ensuring that laboratory business applications, analytical methodologies, instrumentation, automation, and data management techniques are delivered in a GMP compliant manner to meet local and global requirements.

• Responsible for driving all aspects of Validation Life Cycle, Change Control as well as ensuring DI requirements are incorporated and maintained.
• Develop and maintain the Validation Master Plan ensuring it reflects current practices.
• Define and optimize the overall product, process, facilities, and cleaning validation strategies, policies, and programs. Programs to include change control as developed by the QA department. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.
• Manage the development and oversight of validation protocols for all facility services, utilities, equipment, laboratory equipment and systems including computer systems involved in regulatory processes. Engage and oversee analytical test method transfer activities. Manage the development and oversight of the equipment cleaning validation program. This includes the development of a cleaning validation master plan for each unique process or product. Oversees laboratory equipment validation.
• Provide validation technical assistance to other GSK organizations when needed. Participate in cross organizational validation discussion and development effort.
• Determines project resource requirements for engineering/ validation including capacity / capability. Where required assess, appoint, control and direct specific Contractors and Suppliers.
• Work with business clients in identifying, evaluating and initiating strategies to deliver business objectives by developing a partnership relationship with the business areas to which they are aligned.
• Collaborate and influence Global/Regional service providers to ensure specific business-justified application requirements are met.
• Work with business clients, EIS and other supporting IT areas to provide uninterrupted software, hardware, and network service.
• Ensure support processes are in place for laboratory application systems, instrumentation, and automation to maintain the site’s testing and production requirements.
• Work with business clients, EIS and other supporting IT areas to provide uninterrupted software, hardware, and network service.
• Ensure support processes are in place for laboratory application systems, instrumentation, and automation to maintain the site’s testing and production requirements.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree (BS) or equivalent in Chemistry, Engineering, Quality, Pharmaceutical Operations, or a related field
• Minimum 10 years of experience in the pharmaceutical industry (15 years preferred)
• Minimum 7 years of validation experience in manufacturing or development (10…