Senior Director, Quality Systems and Data
GSK
full-time
Posted on:
Location Type: Office
Location: Upper Providence • Pennsylvania • United States
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Job Level
About the role
- 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.
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
Benefits
- US employees are eligible for an extensive benefits program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management SystemsChange ControlDeviation ManagementCAPAGMP TrainingData ManagementDigital Data EnhancementsKey Performance IndicatorsData AnalyticsRegulatory Compliance
Soft Skills
LeadershipStakeholder ManagementStrategic GuidanceCultural AwarenessCapability DevelopmentContinuous ImprovementAccountabilityTraining and AwarenessOperational ExcellenceTeam Performance Management
Certifications
Bachelor’s Degree