Quality Systems & Data Strategy Leader

GlaxoSmithKline; Upper Merion Township (Montgomery County); On-site; USD 180,000 - 240,000; Full time

Job summary

GSK US seeks an Associate Director, Quality Systems & Data to lead a team of quality professionals responsible for data integrity, governance, training compliance, and QMS deployment at the site. You will drive the digital quality strategy (SMART manufacturing), oversee updates to VQMS and MERP, and partner with cross-functional teams to sustain a culture of quality and compliance.

Your leadership will ensure robust quality systems, regulatory alignment, and continuous improvement across data

Qualifications

• B.A./B.S. degree in a science such as Science/ Engineering / pharmaceutical quality.
• 10+ years of industrial experience in a commercial pharmaceutical manufacturing facility.

Responsibilities

• Provide leadership and strategy for site data integrity & governance program working closely with central and site teams.
• Responsible for creating and driving the Quality digital strategy (SMART manufacturing) in collaboration with site and central functions.
• Manages updates to site quality systems including VQMS, MERP through appropriate change management procedures.
• Lead the GSK Quality Management System deployment through effective execution.
• Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes.
• Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.
• Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives and drive initiatives for Quality Culture at site
• Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals.
• Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.
• Provide leadership and direction to a team of 5-15 quality professionals, fostering a culture of quality and compliance.
• Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.

Skills

Data Integrity

Data Quality

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Problem Solving

Project Management

Quality Assurance (QA)

Quality Metrics

Risk Awareness

Technical Writing

Technology Management

Education

B.A./B.S. in Science/Engineering/pharmaceutical quality

Tools

VQMS

MERP

Job description

GSK US seeks an Associate Director, Quality Systems & Data to lead a team of quality professionals responsible for data integrity, governance, training compliance, and QMS deployment at the site. You will drive the digital quality strategy (SMART manufacturing), oversee updates to VQMS and MERP, and partner with cross-functional teams to sustain a culture of quality and compliance.

Your leadership will ensure robust quality systems, regulatory alignment, and continuous improvement across data