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Job Description

About the role

The Associate Director of Quality Control will lead the establishment of a state-of-the-art quality control laboratory. Responsibilities include overseeing its design, construction, qualification, and regulatory approval. Collaborate with global teams to align with Takeda’s laboratory-of-the-future strategy, focusing on automation and paperless systems. Hire and train the Quality Control team, eventually overseeing lab operations to support a 24/7 pharmaceutical manufacturing site.

How you will contribute

·Lead the planning and execution of a new Quality Control Laboratory startup, ensuring full compliance with regulatory standards.

·Design and implement efficient lab processes and workflows to optimize operational performance and throughput.

·Collaborate cross-functionally with IT, R&D, and Manufacturing to ensure seamless system integration.

·Oversee the selection, validation, and implementation of laboratory automation technologies and LIMS platforms.

·Develop and enforce SOPs that uphold the highest standards of safety and quality.

·Manage resources, timelines, and deliverables to ensure a successful and timely lab launch.

·Recruit, train, and lead a high-performing laboratory team, fostering a culture of excellence and accountability.

·Stay current with industry best practices, emerging technologies, and regulatory developments to drive innovation.

·Develop and manage departmental budgets, ensuring alignment with organizational goals and fiscal responsibility.

·Promote team development, engagement, and retention through effective leadership and mentorship.

·Communicate and present effectively to senior leadership and key stakeholders.

·Supervise and support technical teams in a regulated environment, ensuring operational excellence.

·Lead and support regulatory audits and submissions with confidence and precision.

·Maintain clear and consistent communication with the Site Quality Head regarding quality and safety matters.

What you bring to Takeda

·Bachelor’s degree in science, engineering, or a related technical field.

·Minimum of 8 years of industry experience, including at least 3 years in a managerial or leadership role.

·Demonstrated expertise in Quality Assurance, Quality Control, and laboratory startup operations.

·Strong working knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), and EU regulatory standards.

·Proven ability to lead teams and thrive in dynamic, fast-paced environments.

·Proficient in assessing quality risks and authorized to approve or reject laboratory results.

·Active participation in global forums to stay informed on industry innovations and best practices.

·Deep understanding of Quality Control and Sterility Assurance, including experience with technical upgrades and system improvements.

·Skilled in applying risk management principles to daily operations and decision-making.

·Ability to safely manage hazardous and biological materials