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Associate Director – Quality Control
| Company | Takeda |
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| Location | Johnsburg, IL, USA |
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| Salary | $153600 – $241340 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree in science, engineering, or a related field.
- 8+ years of industry experience, including 3+ years in a managerial role.
- Proven experience in Quality Assurance, Quality Control, and lab startups.
- Strong knowledge of FDA, cGMP, and EU regulations.
- Proven ability to manage teams and work in dynamic environments.
- Competence in assessing quality risks, with authority to approve or reject results.
- Participation in global forums to keep updated on best practices and industry innovations.
- In-depth understanding of QC and Sterility Assurance, including technical upgrades.
- Apply effective risk management principles in daily operations.
- Ability to manage hazardous and biological materials safely.
Responsibilities
- Lead startup planning and execution of the Quality Control Lab, ensuring regulatory compliance.
- Design efficient lab processes and workflows.
- Collaborate across IT, R&D, and manufacturing to integrate systems.
- Oversee selection and validation of lab automation and LIMS.
- Develop SOPs to uphold safety and quality standards.
- Manage resources and timelines for successful lab launch.
- Recruit and train a high-performing lab team.
- Stay updated on industry best practices and technologies.
- Develop and manage department budgets and adherence.
- Cultivate team development and retention.
- Present effectively to leadership and stakeholders.
- Supervise and manage a team.
- Lead and support regulatory audits and submissions.
- Maintain effective communication with the Site Quality Head for quality and safety issues.
Preferred Qualifications
No preferred qualifications provided.
