Quality Process and Data Director

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.

Position Summary

The Quality Process and Data Director works with the CMC Quality Systems and Data Sr. Director to transform our key quality management systems across R&D DDS. This includes managing KPI, leading continuous improvement and implementation of enhancements to our quality systems and strategically defining the objectives of the local process owners (change control, deviation, CAPA and GMP training).

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

• Lead the deployment and performance management processes in R&D DDS for Change Control, Deviation, CAPA, Risk Management, Management Monitoring, Quality Council and GMP training.
• Responsible for leading a team that is accountable for deploying the standardized GSK quality business processes in R&D Quality and DDS, analyzing & interpreting quality system metrics and acting on the data analytics to propose process improvements and efficiencies to GBPOs.
• Responsible for developing strong partnerships across R&D Quality and DDS Operational teams to ensure that compliance risks are appropriately identified, escalated, and mitigated.
• Provide leadership and management of R&D SOPs associated with the quality processes to ensure the creation, implementation, and maintenance of harmonized and efficient procedures.
• Ensure the continuous alignment of, compliance to, and effectiveness of R&D processes within the QMS framework and where assigned, provide capability build for R&D QMS content owners, QMS Champions and Local SMEs on phase appropriate QMS implementation.
• Responsible for managing the materials required for quality council and engaging with key stakeholders across the company to prioritize support and risk mitigation.
• Accountable for the content and alignment of the R&D QMS to the legislation, and supporting Pilot Plants during inspections and issue resolution. Providing support for change management and capability build for the Pilot Plants and aligned SMEs related to our quality processes.
• Supports and drives rapid resolution of technical issues escalated from R&D Quality and DDS teams which have a direct connection to one of our quality processes.
• Works with Global and Regional / Local Regulatory to understand, translate and apply local regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements to enterprise quality processes.
• Motivate, focus and develop the team of quality process owners, driving continuous improvement and inclusivity to ensure operational excellence.

Why You?

Basic Qualification

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

• Bachelor's degree
• 10 years' post-graduate experience in the pharmaceutical /biological industry,
• Minimum of 5 years in Quality.
• Experience in the areas of Pharmaceutical Product Development, Quality Management Systems as well as current/emerging regulatory and legal requirements governing, research, manufacturing, supply and distribution of products

Preferred Qualification

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

• Change agent with strong leadership and managerial skills.
• Demonstrated ability to lead, motivate and develop a team of expert staff to deliver consistently high standards, challenge the status quo and deliver sustainable business improvements.
• Has broad knowledge of the GSK business together with an established stakeholder network across R&D and Global Supply Chain.
• Customer focused, able to identify/address user needs and able to influence at all levels of the organization.
• Significant experience in quality systems, digital tools and QMS
• Experience in change control, deviation, CAPA and GMP training would be desirable.
• Proven capacity to drive transformation and manage complex projects and program of projects. Strong in decision-making, problem-solving, and communication.
• Significant Influencing and negotiating skills and verbal and written communications skills
• Demonstrated ability to operate effectively in a matrix organization and engage with other business areas
• Demonstrated ability to think strategically and identify innovative, sustainable solutions to complex business issues
• Demonstrated people development and performance management skills
• Knowledge and experience in operational excellence / continuous improvement techniques and deployment

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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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