Quality Systems Specialist

Quality Systems Specialist

As a Quality Systems Specialist, you will support the day-to-day execution and continuous improvement of Quality Management System (QMS) activities at the Thousand Oaks site. In this role, you will help ensure Quality System processes are implemented, maintained, and executed in a timely and compliant manner while supporting a strong culture of quality, data integrity, and operational effectiveness.

You will serve as a Subject Matter Expert (SME) for assigned Quality System processes and partner closely with Manufacturing, Engineering, Validation, Automation, Laboratories, Maintenance, Metrology, Utilities, and other cross-functional teams. Through your expertise in quality systems, process improvement, data analysis, and compliance, you will help identify opportunities to strengthen processes, improve performance, and sustain a state of compliance.

Provide oversight and guidance for key Quality Management System processes, including Change Controls, Deviations, CAPAs, Document Control, and Supplier Quality, ensuring timely, effective, and compliant execution.

Review, assess, and approve Deviations, CAPAs, Change Controls, and related quality documentation to evaluate potential impacts to products and processes and ensure alignment with applicable quality requirements.

Support continuous improvement initiatives for Quality System processes, including QMS system updates, process effectiveness assessments, and opportunities to improve compliance, efficiency, and data integrity.

Develop, revise, and maintain Standard Operating Procedures (SOPs), forms, and other controlled documentation to ensure processes remain current and aligned with applicable requirements.

Provide Quality Systems guidance and support to cross-functional stakeholders, coordinate and deliver Quality Systems training, and mentor new QMS users to promote consistent application of quality requirements.

Develop and maintain Quality Systems dashboards and reporting tools; analyze and communicate performance trends, risks, and opportunities for improvement across the organization.

Serve as an administrator and subject matter expert for applicable electronic Quality Systems solutions, supporting system functionality, process execution, and continuous improvement.

Support Supplier Quality activities, including supplier qualification, performance monitoring, and resolution of supplier-related quality issues.

Support internal and external audits and inspections as a Quality Systems SME, including audit preparation, report development, response coordination, and timely closure of observations and commitments.

Partner with cross-functional teams to promote a strong quality culture and sustained compliance, serve as a department point of contact and backup when the Quality Systems Manager is unavailable, and perform other duties as assigned.

Bachelor's degree in Science, Engineering, or a related technical discipline strongly preferred.

Minimum of 5 years of experience in Quality required, preferably within a pharmaceutical, biotechnology, or other regulated environment.

Functional knowledge of Quality Systems processes, including nonconformance management, Change Control, CAPA, Document Control, Supplier Quality, and product release required.

Functional knowledge and understanding of global cGMP regulations and Quality Systems requirements applicable to pharmaceutical or biopharmaceutical operations required.

Strong project management, organizational, and analytical skills, with the ability to manage multiple priorities and drive quality initiatives to completion required.

Strong verbal and written communication skills, including the ability to create and deliver presentations to diverse audiences required.

Strong decision-making, interpersonal, and influencing skills, with the ability to effectively collaborate and build relationships across all levels of the organization required.

Advanced Microsoft Excel skills, including data analysis, pivot tables, VLOOKUP/XLOOKUP, trend reporting, and dashboard development required.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict quality and compliance requirements to help ensure the safety and quality of our products. In this role, you may:

Work primarily in a normal office environment.

Perform primarily sedentary work with some light physical activity as required.

Be expected to maintain flexibility in work hours, duties, and responsibilities based on business and operational needs.

Be required to work more than 8 hours per day or 40 hours per workweek as necessary to meet business commitments.

Collaborate regularly with cross-functional teams and personnel across different levels of the organization, including site leadership.

Be required to participate in audits, inspections, quality initiatives, or other activities that may require schedule flexibility.

Be required to speak, read, write, and follow detailed written and oral instructions in English.

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