Quality Process and Data Director
GSK
full-time
Posted on:
Location Type: Office
Location: Upper Providence • Pennsylvania • United States
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Job Level
About the role
- 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
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
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management SystemsData analyticsProcess improvementsChange ControlDeviationCAPARisk ManagementGMP trainingSOP managementRegulatory compliance
Soft Skills
LeadershipTeam managementPartnership developmentStakeholder engagementMotivationContinuous improvementInclusivityOperational excellence
Certifications
Bachelor’s degree