The Associate Dircetor, Quality Systems & Data provides leadership to a team of Quality professionals critical in overseeing Data Integrity and Governance, Training & Training compliance, Quality Management System (QMS) deployment, and providing quality oversight to the Digital Strategy (SMART Manufacturing). The role also includes responsibility for defining and driving the site Quality Improvement Plan and the Quality Culture and support the site Quality Leadership Team for driving Data Analytics & GPS. The Associate Director, Quality Systems & Data reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

• In-depth experience in quality systems, including validation, compliance, and running a high volume, rapid turnaround operation. Strong technical understanding of industry and science practices related to the business.
• Prior experience with leading significant improvement programs.
• Fully versed in GMP's, NIH Guidelines, FDA and other regulatory agency compliance requirements for validation and operations, and analytical and stability functions.
• Strong interpersonal and leadership skills. Solid team player able to function within team-based organization.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, finance and EHS.
• Able to priorities and decide appropriate course of actions.
• Effective at implementing decisions

#LI-GSK

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.