Head, Analytical Controls Sr. Director

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How you will contribute:

• Lead and develop a global team of managers and scientists and their teams in the field of analytical controls and compliance

• Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global reporting

• Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems

• Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge. Including the support of transfer of development assets from Research, main ownership starting at start of GMP activities until hand-over to the commercial organization.

• Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science and across the global Takeda organization.

• Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities

Accountabilities:

• Responsibility for people and group management

• Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment

• Build future leadership while mentoring direct reports and junior employees

• Lead and implementation of wider cross-functional/cross divisional strategy and decisions and drives initiatives to completion.

• Develops and manages strategies for regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads

• Lead global CMC and Quality key initiatives and represent Pharm Sci to other cross functional stakeholder key initiatives

• Analyze and synthesize concepts from diverse information -and articulate

• Develop and set vision and direction of departmental activities and infrastructure with specific focus but not limited to compliance, quality, systems and processes for AD and PS

• In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good/Laboratory/Manufacturing Practice (cGMP, cGLP) regulations

• Harmonization and standardization of AD but also PS processes, reporting, systems and documents in collaboration with Quality. Establishes and manages operational processes within the department/function.

• Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders e.g. GMS/GQ for company wide systems, IT and PSST for new solutions.

• Look for external benchmarks that help to aid superior performance of products, processes and people

• Manages complete line function responsibility for all departmental programs and initiatives

• Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally

• Directs, informs and applies outsourcing strategy for department in conjunction with senior staff and global line and function heads

Minimum Requirements/Qualifications:

• Bachelor degree with 20+ years of experience

• 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 required

• Analytical method development experience required

• Regulatory submission experience required with basic knowledge for regulatory guidelines

• Global cultural awareness, manage inclusively

• Familiarity with working in a global setting

• Excellent command of English (all sites).

• People managerial experience preferred

• Team player with flexible personality but able to be persistent and assertive

• Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement

Takeda is proud in its commitment of 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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