Product Owner

Job Purpose

To 'own' and provide technical control for a product or product family at a local (site) level and to ensure that the product is delivered and maintained to the highest levels of quality and robustness.

Education, Experience & Skills

• Bachelor's Degree or equivalent experience
• Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control.
• Detailed knowledge of dosage form (OSD, Sterile, Injectables) including unit operation understanding, functionality and criticality of formulation materials and their transformations.
• Visual Inspection Program for Sterile and injectable Products. (In-depth Knowledge) E2E Project Lead for Visual Inspection Program.
• Level 1 Facilitator for TRAs ('Proficient' level as defined by the TRA competency framework)
• Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
• Knowledge of regulatory environment, particularly in markets where product is commercialised.
• Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities
• Experienced in technology transfer, with an understanding of the product development process
• Able to evaluate potential innovative technology areas relevant to product
• Thorough knowledge of GMP and EHS requirements
• Demonstrated in-depth knowledge of Quality by Design and risk management approaches
• Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA
• Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders Demonstrated ability to mentor operational staff and support functions

Key Responsibilities

• Principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site as appropriate.
• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation of new products from R&D, and subsequent transfers to other sites.
• Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 APl/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
• Provides leadership and establishes key relationships within site across Production, Technical, Quality and Engineering for the product(s) for which they are accountable, and above site with other Product Owners and R&D.
• May provide leadership to others, such as Technologist roles at site.
• Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews and internal and external audits.
• Provides technical management and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
• Leads Product Technical Review Team (PTRT) if Product Owner for drug product.
• Identifies, develops and trains successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:

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