Quality Technical and Validation Manager

GSK•Marietta, PA

About The Position

This key member of the site quality leadership team has a responsibility and accountability of a team that ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. The role is both inward facing to the site, and outward facing to the GSK network and as an SME to regulators during regulatory inspections. They are pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from and to other supply nodes. Using robust change management practices, they ensure compliance with process, equipment, and computer system validation lifecycle activities, to ensure systems meet regulatory and quality requirements. Doing so ensures compliance with GSK and Regulatory Standards as they apply to Validation and Process Lifecycle Management. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Requirements

Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
10+ years of experience in the pharmaceutical or biotechnology industry, responsible/accountable for decisions and their outcomes.
5+ years of leadership experience.
Experience in developing, approving, and executing process and equipment lifecycle management programs (Continued Process Verification, Validation Master Plans, etc.), and their underpinning protocols and reports.

Nice To Haves

Advanced degree (e.g., Master’s, Ph.D.) in a relevant scientific or engineering discipline.
Strong skills to identify business requirements and to provide solutions to complex issues
Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards for validation and quality assurance.
Certification in quality assurance or validation (e.g., ASQ, ISPE).
Experience with continuous improvement methodologies (e.g., Six Sigma, Lean).

Responsibilities

GxP Oversight of Validation and Qualification Activities. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities.
Determine phase specific controls, and ensure their adherence, for the production and laboratory value streams
New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks and protocols.
Develop, Review and approve equipment validation protocols for all facility services, utilities, equipment, laboratory equipment and systems including computer systems.
Determines change control requirements, including for validation and qualification activities.
Ensure that all validation activities are current and conducted in accordance with GSK's quality standards, regulatory requirements, and industry best practices.
Work with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) in identifying, evaluating and initiating strategies to rapidly developing product transfers by developing a partnership with the business areas to which they are aligned.
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.
Oversee laboratory business applications, methodologies, and automation to ensure they meet quality and compliance standards including their respective Computer System Validation (CSV) requirements.