Product Owner

Business Introduction
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 Product Owner provides technical leadership, guidance, oversight, and support for the associated product or product portfolio, through effective Product Lifecycle Management (PLM) and support for day-to-day operations, to ensure the ongoing manufacture and supply of our products in alignment with Regulatory and Quality standards and business objectives

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

• Provide technical input and support for product transfer, registration, validation and launch.
• Ensure that all aspects of Product Lifecycle Management are in place, actively maintained, and ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed. The key components of the PLM process include: Development History, Material and Technical Risk Assessments, Product Specifications, Control Strategy, Performance Qualification and Continued Process Verification, Periodic Product Reviews, and Product Costing Standards.
• Translate the Control Strategy to the production floor such that Critical Raw Materials attributes, Critical Process Parameters, Critical Quality Attributes and Manufacturing controls are understood, appropriately challenged, agreed, verified, controlled and communicated.
• Perform GEMBAs in production and analytical testing to ensure that the relevant control and verification strategies are in place, in use and effective.
• Lead product failure investigations, escalating significant issues to ensure appropriate support and expertise are provided.
• Trend product performance data, identify and investigate trends and concerns, and communicate to key stakeholders. Present product performance data to the relevant governance meetings (e.g. Product Technical Review Team (PTRT), Communities of Practice and provide input to PPR for assigned products.
• Lead cross-functional teams to evaluate and implement post-approval changes and drive improvements in product control and robustness.
• Work with the supply chain (including primary, excipient and/or component suppliers) to manage inputs that impact the technical performance of allocated products within manufacturing, packaging and testing.
• Provide technical input to regulatory submissions and responses to questions from regulatory agencies. Prepare technical documents, provide technical input and participate in regulatory inspections.
• Contribute to major technology development projects aligned to allocated products

Why You?

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

• Bachelor's degree in a scientific, engineering, or technical discipline.
• 5+ years' experience in regulated manufacturing or product lifecycle roles.
• Experience working with raw materials, equipment, unit operations and testing for Injectables
• Experienced with Product Lifecycle Management, including Control Strategies, Process Qualification, Change Control, and Technical Risk Assessment (L1 TRA Facilitator desired)
• Demonstrable experience as a Product Owner or similar role in regulated environments.

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

• Master's degree or advanced technical qualification.
• Experience with assemblies and devices.
• Experience with technology transfer, scale-up, or commercial launch activities.
• Working knowledge of product control strategies and technical risk assessment methods.
• Familiarity with statistical tools for process capability and trend analysis.
• Experience preparing technical documentation for regulatory submissions or inspections.
• Demonstrated project management or cross-functional team leadership experience.
• Practical experience with product performance monitoring and data trending.
• Experience leading investigations and implementing corrective and preventive actions.
• Familiarity with quality systems, regulatory expectations, and Good Manufacturing Practices.
• Strong stakeholder engagement and communication skills.
• Working knowledge of the raw materials, equipment, unit operations and testing for Injectables.
• Basic understanding of the drug development process.
• Experienced in scale-up and technology transfer.
• Understanding of control strategy principles and application.
• Working knowledge of FMEA techniques.
• Knowledge of cGMPs related ICH guidance (specifically ICHQ8- 11).
• Statistical knowledge and use of Statistica, JMP, SAS, or other data analysis software.
• Experience writing technical protocols and reports.
• Experience preparing for and delivering technical presentations to key stakeholders.
• Experience with investigational techniques and tools for process investigations.
• Ability to navigate critical business systems and databases (e.g. MERP, IP21) and mine relevant data for reporting, review and analysis.
• Familiar with risk-based approach and use of data to design a process qualification strategy, including the selection of batches and development of sampling plans.
• Familiar with cleaning validation approach as it relates to manufacturing operations and limitations.

Working Model
This role is hybrid, with an expectation to be onsite for key meetings and manufacturing support. Exact on-site frequency will be agreed at offer stage and may vary by location and business needs.

What we offer
You will join a team that values collaboration, learning, and purpose. You will find opportunities to grow professionally and to shape work that helps patients worldwide. We welcome applications from people who bring different perspectives and lived experience. If this role matches your skills and ambitions, we encourage you to apply and tell us how you can contribute.

#LI-GSK

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.

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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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