Quality Systems & Data Associate Director

WIB-Pittsburgh; King of Prussia (PA); On-site; USD 170,000 - 230,000; Full time

Job summary

GSK is seeking a Quality Systems & Data Associate Director at its King of Prussia site. You will lead a team to govern data integrity, drive the digital strategy for quality, and oversee QMS deployments, ensuring training compliance and cross-functional alignment.

The role requires deep knowledge of GMPs and regulatory expectations, plus the ability to drive continuous improvement and foster a strong quality culture in a fast-paced manufacturing environment.

Qualifications

• Experience leading quality systems, validation, and compliance.
• Experience managing data governance and training programs.
• Strong knowledge of FDA/NIH regulations and GMPs.

Responsibilities

• Provide leadership for data integrity and governance across site.
• Drive the site digital strategy (SMART manufacturing) and QMS deployment.
• Lead quality systems updates (VQMS, MERP) via change management.
• Oversee deployment of the Quality Management System site-wide.
• Collaborate with cross-functional teams to align quality processes.
• Ensure training compliance and maintain records.
• Develop and monitor the Quality Improvement Plan and culture.
• Stay current with regulatory requirements and industry trends.
• Provide leadership to a team of 5–15 quality professionals and contribute to QLT.

Skills

Data Integrity

Data Quality

Digital Fluency

GxP Regulations

Quality Assurance (QA)

Quality Metrics

Risk Awareness

Technical Writing

Project Management

Lean Management

Problem Solving

Technology Management

Influencing Without Authority

Education

B.A. / B.S. degree in a science such as Science/ Engineering / pharmaceutical quality

Job description

Quality Systems & Data Associate Director

Company: GSK

King Of Prussia, Pennsylvania, United States (on-site)

Posted 17 hours ago

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).

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

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.

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Job ID: 86122871

Websitewww.gsk.com US Headquarters: Philadelphia, PA Size:10000+ employees Founded: 1830 Type: Company - Public (GSK) Industry: Biotech & Pharmaceuticals Revenue: $10+ billion (USD) per year Video: https://youtu.be/RBdgq5VTQmM We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We also have a significant global presence with commercial operations in more than 150 countries, a netwo...