Head of Analytical Controls

3 days ago


Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time
Job Summary

Takeda Pharmaceutical is seeking a highly experienced and skilled professional to lead our Analytical Controls team as Head of Analytical Controls. As a key member of our Pharmaceutical Sciences organization, you will be responsible for developing and implementing strategies to ensure the quality and compliance of our pharmaceutical products.

Key Responsibilities:

  • Lead and develop a global team of managers and scientists in the field of analytical controls and compliance
  • Develop and implement strategies for regional and global departmental infrastructure, resources, projects, and initiatives
  • Represent Pharm Sci to other cross-functional stakeholder key initiatives and lead global CMC and Quality key initiatives
  • Analyze and synthesize concepts from diverse information and articulate key findings
  • Develop and set vision and direction of departmental activities and infrastructure with specific focus on compliance, quality, systems, and processes for AD and PS
  • Collaborate with commercial functions to develop and implement strategies to control quality of drug substances and products based on cGMP, cGLP regulations
  • Harmonize and standardize AD and PS processes, reporting, systems, and documents in collaboration with Quality
  • Benchmark current trends within industry for all areas within Analytical Controls and strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders

Requirements:

  • Bachelor degree with 20+ years of experience or Advanced degree with 15+ years relevant industry experience
  • Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's
  • Demonstrates effective project management skills, GMP and compliance experience, analytical method development experience, and regulatory submission experience
  • Global cultural awareness, manage inclusively, and familiarity with working in a global setting
  • Excellent command of English and people managerial experience preferred

About Takeda Pharmaceutical:

Takeda Pharmaceutical is a global leader in the pharmaceutical industry, committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.



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