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Job Description

Sarà considerato requisito preferenziale l'appartenenza alle categorie protette (legge n. 68/99)

Job Title: Quality Control Lead

Location: Pisa

The Quality Control Lead will report to the Site Quality Head and be responsible to supervise and lead the Laboratory activities including test on raw Materials, final drug product, In Process Control on product, utilities. The candidate will provide technical support in areas of testing, investigations/deviations, troubleshooting, instrument calibration/qualification, and regulatory requirements. The role required a strong degree of technical and compliance leadership within the QC areas.

Key Responsibilities of Quality Control Lead are the following:

• Leading all areas in the Laboratory, providing support and strategy in the following activities:
  • Laboratory testing
  • Laboratory investigations / deviations
  • Laboratory Documentation review
  • Planning and Scheduling of Laboratory Testing Activities
  • Equipment qualification / calibration
  • Laboratory 5S and Lean  program
  • Method transfers

• Manage and lead a team of reports, providing guidance, mentorship, and fostering a collaborative work environment
• Head the quality control laboratory, overseeing  and approving testing, analysis, and documentation processes.
• To ensure that all necessary testing and monitoring program are carried out in accordance with the approved SOP and regulatory requirements. This includes chemical, biological and microbiological test, environmental/critical system monitoring program, materials receiving and inspection
• Manage the release of products by ensuring compliance with established quality standards and specifications.
• Ensure the Compliance of Laboratory Systems with current regulatory requirements  and that all processes and procedures are followed.
• Coach and mentor QC Analysts within their team, supporting their training and development
• Support the development of Quality goals and targets as part of strategic plan and digital roadmap.
• Support and drive continuous improvement initiatives within the Quality Control & Microbiology organization in collaboration with the Site QS&I function and Site Quality Head. This  includes development and introduction of new technologies to maximize efficiency
• Ensure adherence to Laboratory Budget
• Ensure a timely and effective communication and escalation process to Site Quality Head in order to raise up quality and safety issue.
• Collaborate efficiently with colleagues directly or indirectly including
  • Quality Team
  • Manufacturing operations leads and team
  • Operational excellence team
  • Functionsabove site
  • GMP inspection /corporate inspection

• Conduct internal audits, identify areas for improvement, and drive corrective actions.

Qualifications:

• Bachelor of Science in Chemistry or degree in a relevant field such as microbiology, biology, or biochemistry with 5-10 years of proven quality control and analytical laboratory experience with at least 2 years supervisory experience preferred.
• In-depth knowledge of quality management systems, GMP, and regulatory requirements.
• Proven experience within a pharmaceutical regulated industry.
• Strong leadership and team management skills and experience.

• Excellent communication skills in English.
• Familiarity with specialized areas such as analytical instrumentation, automated laboratory systems, validation and current regulatory expectations.
• LSS Qualification (Yellow Belt, Green Belt, Black Belt) preferred.

Technical skills and competences required

• Strong technical leadership and ability to work effectively in a team
• Excellent written and communication skills, as well as experience with presenting to leadership teams.
• Flexible, adaptable to new and innovative ideas.
• In depth knowledge of regulatory standards (both existing and emerging) relevant to the laboratory.
• In depth knowledge of procedures and work practices relevant to the operation of a Laboratory and associated IT Tools.
• Experience with water system validation, environmental monitoring standards and process validation.
• Demonstrated problem-solving skills.
• Demonstrated capability to effectively apply knowledge, manage multiple activities simultaneously and balance priorities to deliver objectives
• Demonstrated ability to work with internal and external colleagues and ability to collaborate effectively with others.

This position requires onsite presence to supervise a 24/7 operational laboratory therefore while occasional remote working may be possible, primarily this is a site based position.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to 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, or any other characteristic protected by law.

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