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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.
Experience with Quality System processes and process improvement tools preferred.
Experience working with electronic Quality Management Systems and/or serving as a system administrator or subject matter expert preferred.
Experience supporting audits, inspections, quality investigations, and regulatory commitments preferred.
Demonstrated ability to identify process improvement opportunities, analyze performance trends, and implement sustainable solutions preferred.
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.
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 #ZR1 #LI-Onsite
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:
USA - CA - Thousand Oaks - Rancho Conejo
U.S. Base Salary Range:
$89,900.00 - $141,240.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
USA - CA - Thousand Oaks - Rancho Conejo
Employee
Regular
Full time
Job Exempt
Yes
