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About the role:

As the Head of Quality Cell Therapy, you will lead and direct the Thousand Oaks Cell Therapy Quality team in Quality processes and activities associated with the manufacturing of the cell therapy products for commercial use in the US. Reporting to the Global Cell Therapy Quality Head, the role will have direct Quality oversight for all cell therapy manufacturing process at Thousand Oaks, including batch disposition and associated QC testing.

You will have experience in Quality processes and in cell therapy technology and sciences. You will be 'enterprise thinker' with an ability to collaborate and work with colleagues within the Global Quality network, and colleagues in Global Manufacturing and Supply, R&D and commercial functions across Takeda.

The Thousand Oaks plant operates 24 hours/day, 7 days/week.

How you will contribute:

• Drive continuous improvement in operations
• Build and implement an organizational structure that is fit for purpose. Drive organizational and individual development through talent review cycles and implementation of development plans to provide an adequate organizational structure, qualification of team members, and compliance of processes.
• Ensure Takeda Quality Management System is applied to the cell therapy medicinal products manufactured on site, considering the unique patient and dosing requirements involved in the products;
• Ensure cell therapy areas readiness for HA inspections and audits. Host inspections of cell therapy operations by third parties (e.g., inspections by notified bodies and by regulatory agencies) and assure implementation of commitments to regulatory agencies.
• Build and lead a team of cell therapy Quality professionals, providing support in the execution of their roles and responsibilities and identify potential successors for management and expert positions.
• Report the status of the operations, including the defined indicators, the goals, the achievements, the gaps, and the opportunities for improvement.
• Drive the local cell therapy Quality organization following OpU goals, provide processes, life cycle management, and optimize yields and capacity.
• Review and approve manufacturing procedures and regulatory documents.
• Collaborate with cross-functional teams including GMS, R&D, Commercial and Regulatory Affairs, to ensure rapid issue resolution, successful product launch and commercialization.
• Ensure compliant disposition of cell therapy products manufactured at the site, according to Takeda´s Customer Service Level expectations;
• Manage Quality budgets, resource allocation and timelines to ensure delivery of high-quality cell therapy products.
• Collaborate with the Global Quality Cell therapy team in identifying and implementing process improvements to increase efficiency and reduce costs.
• Be a subject matter expert on cell therapy Quality topics for internal and external stakeholders, including regulatory agencies.
• Motivate and encourage the plant teams, ensure availability of job-relevant information promptly, and foster collaboration across teams/functions/partners (e.g., other plants, R&D, ..); apply High-Performance Team principles.
• Develop strategic plans and targets to execute goals according to the Global Quality Network strategy and plan.
• Lead the Thousand Oaks Cell Therapy Quality team and direct cell therapy Quality activities.
• Be the main site Quality contact to Global teams in topics associated with Quality processes and activities conducted on site.

What you bring to Takeda:

• Master's degree, preferably in science, engineering, or another related technical field. MBA preferred.
• Prior leadership and project management experience in a manufacturing environment.
• Minimum 10 years of experience in biologics Quality, with at least 3 years of experience in cell therapy manufacturing (clinical or commercial environment).
• Experience working in a matrix organization and across departments and businesses
• Experience in GMP/ISO manufacturing and handling regulatory inspections
• Continuous improvement knowledge; e.g., Black Belt/Lean/Six Sigma certification would be ideal
• Solid professional experience in cell therapy clinical or commercial manufacturing industry, including experience in batch disposition and analytical techniques.
• Manage project and startup/product launch situations
• Experience in General Management to drive Plant performance and investments

What Takeda can offer you:

• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Professional training and development opportunities
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement
• Family Planning Support
• Comprehensive Healthcare: Medical, Dental, and Vision

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• You will be asked to maneuver within a cGMP manufacturing environment, including the ability to gown into classified cleanrooms, final packaging areas, and plant engineering spaces.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• The expected pace is fast, and job completion demands may be high regarding on-time delivery of key objectives and milestones.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be comfortable operating within a cGMP environment, which could include gowning into classified cleanrooms and final packaging manufacturing areas. You should also be comfortable entering plant engineering spaces and QC lab environments.
• Work in a cold, wet environment.

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.

Base Salary Range: $165,000.00 to $ 236,000.00. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors, including, but not limited to, location, skills, education, and experience.

#GMSGQ #ZR1 #LI-MA1

EEO Statement

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, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time