Quality Systems and Data Manager

GSK•Marietta, PA

18h

About The Position

The Quality Systems & Data Manager provides leadership and development to a team of Quality professionals critical in overseeing data integrity and governance, training compliance, Quality Management System (QMS) deployment and enhancement, as well as defining and driving the site Quality Improvement Plan. Enabling the deployment of data visualization tools and AI is a strategic responsibility for this leader. They serve in an outward facing capacity to interface with the broad GSK Quality System network and ensure successful engagement with regulatory agencies during site inspections. The role also includes responsibility for driving the GSK Production System and Data Integrity for Quality and overseeing Quality Culture and Digital Strategy initiatives for the site. The Quality Systems & Data Manager reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT), who contributes to the overall quality objectives for the site. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Requirements

BS or BA in a Science discipline.
7+ years prior experience with licensed biopharmaceutical or biological products.
5+ years prior experience leading an operations or quality assurance team with decision making accountability related to the management or approval of quality systems.

Nice To Haves

Experience with data visualization and AI – competent in using AI as a thought partner
Master’s degree in science or business discipline.
Versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance.
Implementation of global quality systems, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.
Strong communication and problem-solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships
Formal training in quality systems design or administration by a recognized industry organization such as ASQ.
Lean / six sigma training (green belt, black belt, master black belt certification).

Responsibilities

Responsible for creating and driving the Quality digital strategy in collaboration with site and central functions.
Provide leadership and strategy for site data integrity & governance program.
Uses lean six sigma methodologies to advance systemic quality improvements thru the GSK production system.
Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.
Manages implementation of local updates to site quality digital systems and is accountable for maintaining and integrating their respective detailed business processes diagrams so that their end-to-end data flow, and overall compliance, can be understood by end users and external assessors.
Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives.
Accountable for continuously driving improvement in business processes and business systems to improve compliance and productivity over time, thru the monitoring, evaluation, improvement, and effectiveness of those processes and systems and defined frequencies.
Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes, including implementation and maintenance of the Quality Management System (QMS).
Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals. Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.
Drives Quality and DI Culture at the site by interfacing and building partnerships with the GSK Centers of Excellence and other sites to translate data integrity processes and locally maintain standards as appropriate.