Director, Analytical Controls US

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Job Description

OBJECTIVES: 

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

• Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all local 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 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. Including the support of transfer of development assets from Research, main ownership commencing 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.

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.

• Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally. Close alignment and collaboration with other global AC leads in Japan and EU.

• Manages complete line function responsibility for all departmental programs and initiatives. Provides strategic guidance across projects that involve extraordinary, well-considered risks.

• Approve regulatory submission relevant sections, PS usage and justification documents (when applicable)

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

• Support and implementation of wider cross-functional/cross divisional strategy and decisions and drives initiatives to completion. Support of global CMC and Quality key initiatives and representation of PharmSci to other cross functional stakeholder key initiatives

• Analyze and synthesize concepts from diverse information –and articulate

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

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

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

• Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development in alignment and collaboration with partners and stakeholders

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

EDUCATION, BEHAVIOU