Product Owner - Process Validation

About the role

Haleon is looking for a Product Owner to own the process knowledge of the assigned product(s) throughout its commercial lifecycle. The role maintains oversight of process capability through validation activities under the Validation Master Plan to meet cGMP requirements, and keeps processes robust, validated and continuously improving at site and CMO.

Key responsibilities

• Act as principal point of contact for current and previous product knowledge, including critical quality attributes (CQAs) and critical process parameters (CPPs), and share it across site and globally
• Liaise with Regional and Global Technical, QA, QC, Engineering and Operations to ensure products are manufactured in a validated state of control
• Take part in product committees such as the Product Technical Review Team, helping plan, prioritize and monitor improvements to weaker products
• Implement and maintain continued process verification (CPV), using data trending and statistical analysis to confirm processes stay in control and spot emerging risks
• Participate in trend review meetings and contribute technical expertise to improve product Ppk
• Maintain and review product control strategies (PCS) and technical risk assessments (TRA), and lead or contribute to change controls, product transfers, major deviations and investigations
• Run cleaning validation campaigns, including DEHT and CEHT, and prepare equipment performance qualification protocols with Engineering, Production and Quality
• Ensure compliance with GMP, quality, EHS and other applicable policies

Required profile

• Pharm-D, MSc or Engineering degree
• 5+ years of experience in pharmaceutical operations, technical or new technology roles
• Strong interpersonal and communication skills, able to work across a diverse customer base
• Awareness of FDA, US pharma and GMP requirements related to packaging
• Ability to work in a matrix organisation across geographies and cultures