- The Senior Manager, IMP Quality Systems & Compliance develops, implements, and manages GMP compliance strategies and processes for the regional IMP Quality and Pharmaceutical Sciences organizations.
- This position is directly responsible for a team of GMP Quality subject matter experts and manages the development, implementation, and maintenance of GMP supplier quality operations for the IMP supply chain (manufacturing, packaging, testing, and distribution).
- The Senior Manager, IMP Quality Systems & Compliance develops strategic direction and ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in Chemistry, Biology, Engineering or related field. Masters preferred.
- Minimum of 10 years of increasing responsibility and experience in the global pharmaceutical industry. At least 3 years of managerial experience
- Minimum of 7 years of Quality/cGMP Compliance experience.
- Experience working with a global outsourced-based supply chain.
- Ability to effectively present information and respond to questions from Senior Leadership, peers, and external personnel.
- Strong understanding of the establishment and use of KPIs and operational metrics to gauge and improve third-party vendor performance.
- Ability to manage multiple tasks, meet deadlines, and work under pressure in a fast paced environment.
- High level of integrity and dependability with a strong sense of urgency and results-orientation.
- In-depth understanding of international pharmaceutical regulations and requirements governing the pharmaceutical industry.
- Ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner. Ability to negotiate and collaborate with others.
- Capable of analyzing a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
- Effectively lead and motivate a team of direct reports, builds on strengths, and address areas for improvement.
Able to establish/maintain professional relationships and rapport with internal and external peers and higher-level management. Essential skills include collaboration, maintenance of focus, consensus-building, negotiation and conflict resolution, de-escalation, relevant concept identification and focus on facts, and listening.
- Routine demands of an office based environment.
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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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