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 projec