Manage Technical activities across multiple dosage forms with contract manufacturing companies and internal manufacturing sites to support product transfers, and new product introductions (NPIs) while partnering with QA, Commercial, R&D, and central Technical teams and internal sites to meet business needs.
• Lead technical troubleshooting and continuous improvement on CAPA effectiveness
• Ensure effective and efficient fit for purpose technical processes are in place to support Product Transfer, NPI, registration and launch.
• Work as companies single point of contact for all Technical activities across multiple CMOs producing company products.
Key Responsibilities (10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
• This is a key role assuming responsibility for all Technical activities for CMOs within scope of Supplier Relationship Team (SRT) including:
o Product / Process assessments and continuous improvement at CMOs
o Oversight and implementation of validation activities impacting company products
o Troubleshooting and CAPA implementation / effectiveness for technical related issues
o Product transfer and NPI technical oversight and accountability
• Support the Americas Technical Support Lead in development and application of standard work across the CMO network, including implementation of Product Lifecycle Management (PLM) and Performance Management activities
• Work effectively within the matrix management structure to properly engage and drive performance from CMO Technical teams and pull in proper support from wider company network Technical resources when needed
• Support regional governance routines to track site performance vs plan and facilitate complex issue resolution.
• Develop and maintain the knowledge system to leverage troubleshooting experience and improve CAPA effectiveness
• Coach and develop technical talent within CMOs and internal sites.
• Represent the technical function and actively participate in regular SRT leadership meetings to drive business and Quality performance goals in the CMO network
• Colleague will work independently on most assignments and will be primarily accountable for identifying and prioritizing the projects / activities he / she is assigned to.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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