Quality Systems & Data Associate Director

GlaxoSmithKline; King of Prussia (PA); On-site; USD 140,000 - 180,000; Full time

Job summary

GSK is seeking an Associate Director, Quality Systems & Data to lead site data integrity and governance, drive the digital quality strategy, and oversee QMS deployment. You will manage updates to quality systems and ensure training compliance across personnel, collaborating with site and central teams.

The role requires a senior level in GMP environments, with strong leadership, communication and strategic thinking to advance quality culture and continuous improvement within the site Quality

Qualifications

• B.A./B.S. in science or engineering, or pharmaceutical quality.
• Experience in GMP, FDA and regulatory compliance guidance.
• Proven leadership in quality systems and data governance.

Responsibilities

• Provide leadership to a team of 5–15 quality professionals.
• Drive site data integrity & governance program with cross-functional teams.
• Lead the quality digital strategy (SMART manufacturing) at the site.

Skills

Data Integrity

Data Quality

Digital Fluency

GxP Regulations

Influencing

Lean Management

Problem Solving

Project Management

Quality Assurance

Quality Metrics

Risk Awareness

Technical Writing

Technology Management

Education

B.A./B.S. in Science/Engineering/Pharmaceutical Quality

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: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 siteMaintains 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-GSKSkillsData 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 ManagementPlease 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] 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/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/