Posted to MedZilla on 4/25/2017


Takeda Pharmaceuticals

US-MA, Sr. Manager, IMP Quality Systems & Compliance 1700289-MZ


 
 

OBJECTIVES:
  • 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.

ACCOUNTABILITIES:

  • Develop and lead the strategy for assessing and ensuring the GMP quality and compliance performance of Takeda s pharmaceutical development supply chain.
  • Implement and manage processes for monitoring the compliance of key Takeda vendors and tracking quality performance metrics. Partner with internal stakeholders in providing feedback and direction to improve vendor performance and ensure ongoing compliance.
  • Foster effective partnerships with internal Takeda stakeholders (e.g. Pharmaceutical Sciences, Procurement, Global Quality Auditing) to identify and qualify new third-party vendors, ensure fulfillment of annual audit requirements, and manage quality/compliance at existing key vendors.
  • Develop and manage a process to ensure Quality Agreements are written, approved, and controlled for all applicable GMP vendors.
  • Manage the Stock Recovery Process to oversee the removal, recovery, or correction of Takeda s clinical trial materials when and if determined necessary.
  • Interact with and influence colleagues in IMP Quality, R&D Quality Systems & Compliance and Global Quality in order to strategically align and facilitate harmonization of quality systems, procedures, and processes where necessary.
  • Track, analyze and report on GMP metrics in order to monitor internal GMP compliance and the effectiveness of processes within the pharmaceutical quality system. Communicate such information to senior management in IMP Quality and Pharmaceutical Sciences in a timely and effective manner.
  • Develop and manage a process to ensure training matrices for IMP Quality personnel are created and kept current so that employees have the appropriate level of training necessary to successfully carry out their responsibilities.
  • Maintain awareness of emerging issues and regulatory trends, provide interpretation, and communicate effective impact assessments and mitigation plans to management.
  • Additional duties as assigned.
Qualifications

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.
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • Requires approximately 10% travel, both domestic and international.



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