Director of Analytical Controls and Compliance

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
Job Description

Key Responsibilities:

  • Lead and develop a team of managers and scientists in the field of analytical controls and compliance.
  • Oversee and manage core tasks for analytical controls for clinical trial material efforts across four main areas: GMP review and control for analytical documents, release testing oversight, stability and shelf life, and reference standard management.
  • Contribute to product development and product quality oversight from research to commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process, and product knowledge and control.
  • Represent the function within CMC/Pharmaceutical Science and across the global Takeda organization.

Accountabilities:

  • Responsibility for people and group management, inspiring confidence in team members and leading the organization culture.
  • Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally.
  • Manages complete line function responsibility for all departmental programs and initiatives.
  • Approves regulatory submission relevant sections, PS usage, and justification documents.
  • Contributes and manages strategies for regional and global departmental infrastructure, resources, projects, etc.

Requirements:

  • Bachelor's degree and 18+ years of relevant industry experience.
  • Masters and 16+ years of relevant industry experience.
  • PhD and 10+ years of relevant industry experience.
  • Minimum of 7 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.

About Takeda:

Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We are 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.

Benefits:

We offer a competitive salary range of $169,400.00 - $266,200.00, medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.

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