Quality Assurance Head

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Job Description

Quality Assurance Head Cell Therapy

Location: Grange Castle

About the role:

The Quality Assurance (QA) Head, Cell Therapy will manage the oversight of all operational quality activities associated with the manufacturing and disposition of product at Takeda Ireland Limited Grange Castle. The QA Head ensures all Cell Therapy commercial products are manufactured following cGMP, Corporate and Regulatory requirements. The QA lead executes the site QA activities to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of our business and global markets.

This role must ensure interaction with other departments regarding GMP Document review and drug substance/Drug Product release. You will ensure the deployment of QA resources for all Grange Castle product operational activities.

Leadership/People: No of direct reports: 5.

Hybrid (80/20)

How you will contribute:

The primary responsibilities of the Quality Assurance Head Cell Therapy include the following:

• Lead and Mentors the QA Operations team to operate independently and cohesively to deliver excellence in Quality and Compliance support to relevant.
• Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply.
• Be the quality point person, providing guidance and feedback on quality assurance issues.
• Be designee for the Quality lead in their absence.
• Ensure documentation, investigations and reports are reviewed and approved promptly, highlighting and assisting in the resolution of issues determined by the level of risk.
• Oversee the application of Risk Management Principles at the Takeda Ireland Limited Grange Castle (TILGC) P3 facility.
• Ensure schedules for approval of GMP documents are maintained to meet the needs of Commercial Operations.
• Provide comprehensive QA support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for commercial products.
• Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.

What you bring to Takeda:

• QP qualified highly desired.
• 15 years relevant experience in the pharma industry or a related field.
• 3 years managerial experience.
• Aseptic manufacturing experience is essential
• Knowledge of cGMP requirements for pharmaceutical manufacturing required.
• Direct experience of GMP management within a pharma/biopharma company is necessary and will include exposure external/internal inspections.
• Experience working with regulatory bodies and hosting regulatory inspections.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programmes including onsite flu shots and health screenings

Educational Assistance

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

Empower 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, colour, 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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