Quality Process and Data Director

GSK•Upper Providence Township, PA

About The Position

The Quality Process and Data Director works with the CMC Quality Systems and Data Sr. Director to transform our key quality management systems across R&D DDS. This includes managing KPI, leading continuous improvement and implementation of enhancements to our quality systems and strategically defining the objectives of the local process owners (change control, deviation, CAPA and GMP training). 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
10 years’ post-graduate experience in the pharmaceutical /biological industry,
Minimum of 5 years in Quality.
Experience in the areas of Pharmaceutical Product Development, Quality Management Systems as well as current/emerging regulatory and legal requirements governing, research, manufacturing, supply and distribution of products

Nice To Haves

Change agent with strong leadership and managerial skills.
Demonstrated ability to lead, motivate and develop a team of expert staff to deliver consistently high standards, challenge the status quo and deliver sustainable business improvements.
Has broad knowledge of the GSK business together with an established stakeholder network across R&D and Global Supply Chain.
Customer focused, able to identify/address user needs and able to influence at all levels of the organization.
Significant experience in quality systems, digital tools and QMS
Experience in change control, deviation, CAPA and GMP training would be desirable.
Proven capacity to drive transformation and manage complex projects and program of projects. Strong in decision-making, problem-solving, and communication.
Significant Influencing and negotiating skills and verbal and written communications skills
Demonstrated ability to operate effectively in a matrix organization and engage with other business areas
Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues
Demonstrated people development and performance management skills
Knowledge and experience in operational excellence / continuous improvement techniques and deployment

Responsibilities

Lead the deployment and performance management processes in R&D DDS for Change Control, Deviation, CAPA, Risk Management, Management Monitoring, Quality Council and GMP training.
Responsible for leading a team that is accountable for deploying the standardized GSK quality business processes in R&D Quality and DDS, analyzing & interpreting quality system metrics and acting on the data analytics to propose process improvements and efficiencies to GBPOs.
Responsible for developing strong partnerships across R&D Quality and DDS Operational teams to ensure that compliance risks are appropriately identified, escalated, and mitigated.
Provide leadership and management of R&D SOPs associated with the quality processes to ensure the creation, implementation, and maintenance of harmonized and efficient procedures.
Ensure the continuous alignment of, compliance to, and effectiveness of R&D processes within the QMS framework and where assigned, provide capability build for R&D QMS content owners, QMS Champions and Local SMEs on phase appropriate QMS implementation.
Responsible for managing the materials required for quality council and engaging with key stakeholders across the company to prioritize support and risk mitigation.
Accountable for the content and alignment of the R&D QMS to the legislation, and supporting Pilot Plants during inspections and issue resolution. Providing support for change management and capability build for the Pilot Plants and aligned SMEs related to our quality processes.
Supports and drives rapid resolution of technical issues escalated from R&D Quality and DDS teams which have a direct connection to one of our quality processes.
Works with Global and Regional / Local Regulatory to understand, translate and apply local regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements to enterprise quality processes.
Motivate, focus and develop the team of quality process owners, driving continuous improvement and inclusivity to ensure operational excellence.