GSK · 16 hours ago
Quality Process and Data Director
USA - Pennsylvania - Upper Providence
Full-time
Onsite
Director/Executive
10+ years expGSK is a global biopharma company focused on uniting science, technology, and talent to improve health outcomes. The Quality Process and Data Director will lead the transformation of quality management systems across R&D DDS, managing key processes and driving continuous improvement initiatives to ensure compliance and operational excellence.
BiotechnologyHealthcarePharmaceuticalHealth Care
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
Qualification
Required
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
Preferred
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
Benefits
Comprehensive benefits program GSK offers US employees
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Luke Miels
Chief Executive Officer
Julie Brown
CFO
Recent News
Markets | Mail Online
2026-02-05
2026-02-03
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