Manufacturing Process Product Owner
HaleonAbout the role
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
About the role
As a Manufacturing Process Product Owner you will effectively and independently own and lead all elements of the Product Lifecycle for the site's products.
Role Responsibilities
- Recognized as the 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 CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
- Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s), including cleaning of products: Technical, Product Control Control Strategy to standard work as batch manufacturing instructions as per the principles), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and as appropriate 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 commercialization of new products from R&D, and
subsequent transfers to other sites. The Product Owner is responsible for the completion of all TRA, MMI (site specific), batch records and recipes for all NPIs and Technical transfers.
• 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 that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose 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 , Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
- Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
- Provides technical leadership 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 PTRT) if Product Owner for drug product.
- Identifies, develops and trains successors for the role, and coaches others in their area , ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.
- Review opportunities for batch processing improvements
and waste reduction. Work with a cross functional team to
implement as required.
Why you?
Basic Qualifications:
- Bachelor’s degree in engineering (Chemical, Mechanical, Electrical or a related field scientific field)
- 5+ years' experience in a process, manufacturing, project, or R&D engineering position
- Experience in Pharmaceutical/FMCG or other regulated industry
- Experience working in a manufacturing environment, including manufacturing process and equipment.
Preferred Qualifications
- Detailed knowledge of relevant dosage forms including unit operation understan
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