Product Owner

GSK•Zebulon, NC

10d•Hybrid

About The Position

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

Requirements

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.

Nice To Haves

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.

Responsibilities

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