Product Owner, CMO (Consumer Healthcare)
Position: Full time
Open date: Aug 16, 2019
Functional area: Manufacturing
- Manages Technical activities across multiple dose forms and contract manufacturing companies to support product transfers, and new product introductions (NPIs) while partnering with QA, Commercial, R&D, and central Technical teams to meet business timelines.
- Lead technical troubleshooting and continuous improvement on CAPA effectiveness.
- Ensure effective and efficient fit for purpose processes are in place to support Product Transfer, NPI, registration and launch.
- Works as GSK single point of accountability for all Technical activities across multiple CMOs producing GSK product.
- Assumes accountability for all Technical activities for CMOs within scope of Supplier Relationship Team (SRT) including:
・Product / Process assessments and continuous improvement at CMOs
・Oversight and implementation of validation activities impacting GSK products
・Troublshooting and CAPA implementation // effectiveness for technical related issues
・Product transfer and NPI technical oversight and accountability
- Ensuring all aspects of Product Quality Lifecycle Management are actively applied to the products at CMOs including a current Technical Risk Assessment, current Product Control Strategy and an appropriate means of pro-actively trending performance of the product, including stability, highlighting trends to CMO and Quality representative, and making recommendations for continuous improvement.
- Works effectively within matrix management structure to properly engage and drive performance from CMO Techncial teams, and pull in proper support from wider GSK network including CH and Rx Technical resource.
- Provides technical leadership on behalf of the GSK during technology transfer of products into and out of CMOs ensuring Quality by Design principles are applied and a robust, well understood process is transferred with a well-defined and appropriate Product Control Strategy.
- Partner with CMO Process Engineering team to effectively design and implement validation strategies across the CMO supply base.
- Actively participate in regular SRT leadership meetings to drive business and Quality performance goals in CMO network
- Is involved in the assessment and management of all aspects of post-approval change to ensure that product quality is maintained and the appropriate change controls are in place.
Minimum 5-7 years pharmaceutical manufacturing / technical environment in geographical region in question:
• Experience in CMO (Contract Manufacturing Operation) environment
• Experience in complex technical troubleshooting, RCA and CAPA effectiveness
- Leadership and execution of scale up, tech transfers, process validation projects
- Good project management, communication, negotiation, and problem solving skills
- Demonstrated leadership in a global, matrixed environment in the pharmaceutical industry
- Business acumen to drive continuous improvement and interact with external company Executive teams on behalf of GSK
Education: BS in Science or Engineering (Pharmaceutical, Chemical, Biomedical, Food Science)
- Fundamental understanding of product / processes
- Japanese and English business level (reading, writing, speaking, listening)
- Masters degree (Science or Engineering and/or Business)
- Benefit from deep technical or business understanding
At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Our mission is inspiring and challenging - to help people do more, feel better and live longer.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centers throughout the globe.
For more info about our consumer healthcare business please check below link:
You may apply for this position online by selecting the Apply now button.
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