Quality Systems & Data Associate Director

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

At GSK, we manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

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:

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.

Basic 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.

Preferred Qualifications

• 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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail] GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.