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Job Description

Job Title: Quality Compliance Specialist

Location: Thousand Oaks, CA

About the role:

As a Quality Compliance Specialist, you will manage external regulatory inspections and responding to regulatory observations while leading GMP compliance initiatives.

This is an on site role that reports to the Quality Compliance Manager

How you will contribute:

• Manage external regulatory inspections, lead local inspection readiness efforts, oversee inspection and support rooms, escorting regulatory agents as needed, and serve as a subject matter expect during inspections.

• Draft responses to regulatory inspection reports, collaborating with multiple departments under short deadlines to ensure accurate and appropriate responses.

• Drive on-time completion of corrective action commitments made to regulatory authorities.

• Coordinate efforts associated with GMP re-certification and product licensing.

• Lead and support initiatives to mitigate top GxP compliance risks, providing consultation, guidance, and serving as a plant resource for facility compliance. Adhere to domestic and international GMP regulations and cGMPs.

• Be the point person for regulatory intelligence and changes that impact the site, communicate relevant regulatory findings from other sites, lead mitigation efforts, and identify site gaps based on other site's findings and global documents.

• Participate in local cGMP walkthroughs and conduct quality audits to ensure compliance with cGMPs and Quality Management System requirements.

• Participate in Quality Management Review program, lead Self-Inspection program and be the site contact for Quality Incident.

• Champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation. May participate or lead continuous improvement teams (e.g. DMAIC, Lean, Kaizen), improving quality and compliance.

• Be an area department contact and back-up when Quality Compliance Manager is not present.

• Support product complaints and perform other duties as needed.

What you bring to Takeda:

• Bachelor's degree in science or engineering.

• Minimum 5 years of experience in Quality.

• Experience with quality auditing and with process improvement tools preferred.

• Knowledge and understanding of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations.

• Strong knowledge of biologic manufacturing processes (e.g. cell culture, purification, aseptic filling), laboratory operations (analytical and microbiology), and plant critical systems. Knowledge of sterile product/aseptic processing is desirable.

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:

• Overall physical exertion of this position is mostly sedentary, with some light physical work.

• Able to occasionally visit controlled or clean room environments requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• May work in a cold, hot or wet environment.

• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Although assignments will be made specific to working hours, flexibility is expected, with the understanding that there may be changes in work hours, duties, and responsibilities.

• Must be able to work more than 8 hours a day or 40 hours a workweek as required.

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.

#GMSGQ

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

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.

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Job Exempt