Purpose
The Outsourcing Manager is the single point of contact for the internal project development teams, QA, Business Operations, and external service providers.
The position strategically coordinates global outsourcing activities to meet pipeline needs and given development timelines and budget, and assumes people-management responsibility for leading and developing a team. Existing processes are continuously challenged and further developed together with internal and external interfaces to increase their effectiveness. The role requires a high level of organizational, documentation, and communication skills.
Responsibilities
- Manage and lead interactions with service providers and represent AbbVie’s interests by supporting externalized early-phase development projects.
- Strategically coordinate, plan, schedule, and monitor development work in formulation, manufacturing process development, and analytics within the given project timelines.
- Maintain an overview and assessment of existing service providers and proactively drive the identification and qualification of new external partners.
- Prepare and file GMP-compliant documents and review analytical service-provider data.
- Prioritize activities and work packages and work with different areas to drive standardized, GMP-compliant, and effective outsourcing processes.
- Develop and continuously improve appropriate management systems.
- Collaborate in global teams with internal and external partners.
- Obtain and evaluate proposals and support contract preparation.
- Contribute to the planning of and adherence to the budget for assigned projects.
- Contribute to the preparation, review, and negotiation of technical quality agreements, with a focus on analytical requirements.
- Lead and develop a team and ensure compliance with GMP training requirements.