Job Title
Quality Control Lead
Location
Pisa
Key Responsibilities
- Lead all areas in the Laboratory, providing support and strategy for activities such as:
- Laboratory testing
- Investigations and deviations
- Documentation review
- Planning and scheduling of testing activities
- Implementing Laboratory 5S and Lean programs
- Method transfers
- Manage and mentor a team of reports, fostering a collaborative environment
- Oversee laboratory testing, analysis, and documentation processes
- Ensure testing and monitoring comply with SOPs and regulatory requirements, including chemical, biological, microbiological tests, and environmental monitoring
- Manage product release ensuring quality standards are met
- Maintain compliance of laboratory systems with regulatory standards
- Coach and develop QC Analysts
- Support strategic quality goals and digital initiatives
- Drive continuous improvement within the QC & Microbiology teams
- Manage laboratory budget
- Ensure effective communication and escalation processes
- Collaborate with quality, manufacturing, operational excellence, and other functions
- Conduct internal audits and implement corrective actions
Qualifications
- Bachelor of Science in Chemistry with 5-10 years of QC and analytical lab experience, including 2 years supervisory experience
- Deep knowledge of quality management, GMP, and regulations
- Experience in the pharmaceutical industry
- Strong leadership and communication skills in English
- Familiarity with analytical instruments, automation, validation, and regulatory standards
- LSS Yellow/Green/Black Belt preferred
Technical Skills
- Technical leadership and teamwork
- Excellent communication and presentation skills
- Adaptability and innovation
- Knowledge of regulatory standards, water system validation, environmental monitoring, and process validation
- Problem-solving skills
- Ability to collaborate effectively
This role requires onsite presence to supervise a 24/7 laboratory, with occasional remote work possible.
About Us
Takeda is committed to transforming patient care with innovative pharmaceuticals and support programs. We are a global Top Employer fostering an inclusive, collaborative, and excellence-driven workplace, dedicated to delivering Better Health worldwide.
Equal Opportunity
Takeda is proud to promote diversity and equal employment opportunities for all applicants and employees, regardless of background or characteristics.