Quality Technical and Validation Manager

GSK•Zebulon, NC

3d•Hybrid

About The Position

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. It involves organizing and directing all validation activities, including capital projects, and working with operations to require 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. The role ensures robust and compliant validation and change control efforts and provides 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.

Requirements

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 years preferred)
Experience with analytical equipment and analytical method validation
Proven experience managing validation projects, including capital projects
Experience leading validation teams or high-paced operational/quality-focused teams
Background in laboratory operations, laboratory applications, or IT within a scientific environment
Strong technical expertise in chemical theory, analytical methodologies, laboratory and microbiological instrumentation, and computer applications related to pharmaceutical analysis

Nice To Haves

Strong foundational understanding of departmental resourcing and technical concepts
Demonstrated knowledge and core competencies gained through relevant academic programs
Strong analytical skills to identify business requirements and to provide solutions to complex issues.
Working knowledge of cGMP regulations including process validation/product characterization guidelines.
Analytical validation and transfer expertise.
Must be able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, regulatory, and operational disciplines.
Capable of providing direct supervision in a team-oriented atmosphere.
GPS training or equivalent preferred.
Excellent written and verbal communication, presentation, report writing, influencing, listening and networking skills.
Demonstrated initiative and results focused problem solving/troubleshooting skills.
Good understanding of site business drivers.
Proven ability to influence others and foster collaboration.
Proven ability to champion change and innovation.

Responsibilities

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.