CMC Quality Systems and Data Senior Director

GSK•Upper Providence Township, PA

11d

About The Position

The role is responsible for defining and implementing the vision and strategy that translates our global quality standards into efficient, innovative, and compliant R&D processes that enhance our business performance and create a competitive advantage. This includes overseeing core Quality Systems and Processes (e.g., Documentation, Change Control, Deviation, CAPA, and GMP training), driving Quality digital transformation, continuous improvement, and governance within Quality Systems and Data. As a key member of the Quality R&D Leadership Team, the role ensures alignment with the Global Quality QS&D team, fosters a culture of learning and capability development in R&D Quality and DDS, and supports compliance with regulatory requirements, audits.

Requirements

Bachelor’s degree
10 years’ experience in Quality function in a highly regulated environment.
Experience of working at a senior level across various geographical regions and different cultures.
Experience in strategy development and deployment, change / stakeholder management and business improvement.
5 years’ leadership experience across functions and organisational levels.
Experience in the areas of Quality Management Systems as well as current/emerging regulatory and legal requirements governing the manufacturing, supply and distribution of products

Nice To Haves

Advanced degree in a relevant scientific or technical discipline.
Experience implementing electronic quality management systems or manufacturing execution systems.
Hands-on skills with data analytics tools, data visualization, or data governance platforms.
Experience supporting regulatory inspections and interacting with regulatory agencies.
Familiarity with project management practices and tools.
Prior experience coaching or leading small teams.

Responsibilities

Define and implement the vision and strategy to translate Quality standards into innovative, compliant, and efficient R&D Quality processes that drive operational excellence and value creation.
Oversee, and optimize core Quality Processes, including Documentation, Change Control, Deviation, CAPA, GMP Training, phase appropriate QMS implementation, Quality Council, Data Management.
Accountable for ensuring robust, simple and standardized quality processes, change management and deployment across R&D, including implementing digital data enhancements and foundations.
Ensure quality management for validation and qualification of equipment, facilities and computerized systems in alignment with regulatory and company global requirements.
Drive digital transformation initiatives, leveraging GPS principles to improve systems, governance, data analytics, and reporting capabilities.
Establish and monitor key performance indicators (KPIs) for Quality Systems and Processes to ensure effective quality governance and continuous improvement across operations.
Foster a culture of learning and capability development by sponsoring initiatives such as Learning Zone, Training Academy, and Competency-Based Learning models.
Lead the development of the Quality R&D QS&D team by enhancing skills and competencies, managing individual and team performance, and fostering behaviors aligned with GSK’s culture and leadership expectations.
Drive data management excellence, by promoting a culture of accountability through governance, training and awareness initiatives. Provide strategic guidance to ensure data-related projects uphold ALCOA principles and aligned with organizational objectives.
Provide support during regulatory inspections, global audits, and internal audits, conduct site operations oversight through GEMBA walks or other effective methods to ensure compliance and operational excellence