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Job Description About the role :
The Quality Compliance Lead supports various quality programs to ensure organizational compliance. This role involves managing and monitoring the organization's processes and products to ensure they adhere to regulatory and internal quality standards. The role involves leading audit readiness plans for internal and external inspections and risk management programs, leading and conducting self-inspections, and leading continuous improvement initiatives to uphold quality and regulatory compliance. This role also supports the review of Product Quality Review, Site Master File, Observation Review, and KPI Programs, as well as license renewals and regulatory submissions and preparing for audit readiness.
Key Responsibilities :
- Audit Readiness and Regulatory Compliance operations.
- Risk Management.
- Data Compilation and Analysis.
- Product Quality Review and GxP Documentation.
- Communication and Issue Reporting.
- Continuous Improvement Projects.
- Task Management support.
How you will contribute :
Lead the site audit readiness plan, including Gemba walks, gap assessments, and SME preparation and logistics to ensure successful internal and external inspections.Assist with authoring written responses to internal and external inspections.Perform gap assessments during Observation Review programs and ensure that citations received by other facilities are disseminated to appropriate management teams for evaluation and remediation.Track / trend action plans, provide compliance expertise, and oversee timely closure of commitments.Play a key role in the support rooms by reviewing documentation and partnering closely with quality, manufacturing, and other supporting business units.Lead sweeps to ensure Good Manufacturing Practices are followed during inspection tours.Review documents for accuracy and correctness for license renewals and regulatory submissions.Lead and perform planned self-inspection audits to ensure compliance with regulatory requirements and company policies.Lead and manage risks identified and included in the Risk Register.Responsible for performing Observation Review Process gap assessment and driving actions resulting from the evaluation.Lead and support efforts of the annual Product Quality Review.Perform technical review and analysis of statistical data for key quality indicators and metrics during the Quality Council.Support the preparation of quality compliance metrics for SISR.Support the maintenance and technical review of the Site Master File updates.Provide NEO training to new employees on GMP regulations and compliance.License Renewal : Supporting documentation management from regulatory bodies and internal customers.Regulatory Trends Knowledge : Partner with regulatory intelligence teams to remain current on proposed regulations and regulatory enforcement trends.Audit Workflow Management : Responsible for the audit workflow in the QMS system and other system databases.Quality Goals Achievement : Manage self-activities to achieve defined quality goals efficiently, accurately, and on time.Serve as a resource within the plant and interact frequently with functional peers and senior group managers.Planning and execution of activities.Interface with quality, manufacturing, and technical support groups to resolve issues related to Quality Compliance.Provide innovative solutions and drive continuous improvement initiatives.Actively participate in operating mechanisms at defined frequencies.Apply problem-solving methodologies and act as a consultant to other facilities.Apply digital tools to ensure efficiency.Notify management of potential issues that could jeopardize the effective release of acceptable products to internal and external customers.Minimum Qualifications :
Bachelor's degree in a Science or engineering-related field (e.g., Quality Assurance, Regulatory Compliance, Business Administration).Minimum of 5 years of experience in quality assurance, regulatory compliance, or a related field.Strong knowledge of regulatory requirements and quality standards.Demonstrate strong communication (written and verbal) and presentation skills.Thorough knowledge of applicable procedures, specifications, and quality standards.Excellent data analytical, critical thinking, risk management, continuous improvement, organizational, communication, and project management skills.Proficiency in using quality management software and digital tools.Ability to prioritize workflow and handle multiple activities and meet deadlines.Must be self-directed and motivated to complete tasks by following guidelines, procedures, and policies.Ability to diplomatically and professionally interact well with coworkers, cross-functional team members, and internal / external customers.Must be proficient in written and oral English.What you bring to Takeda :
Required : Typically requires bachelor’s degree in science, engineering, or other related technical field. 3 years of related experience.Strong knowledge of regulatory requirements and quality standards.Desired : Experience in the pharmaceutical or healthcare industry.Certification in quality assurance or regulatory compliance (e.g., CQA, CRCP).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 :
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.Must be able to lift, push, pull, and carry up to 20 lbs.May work in a controlled environment requiring special gowning and wear protective clothing.May work in a cold, hot, or wet environment.May work multiple shifts, including weekends.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.
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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 :
USA - CA - Los Angeles
U.S. Base Salary Range :
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
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.
Locations USA - CA - Los Angeles Worker Type Employee Worker Sub-Type Regular Time Type Full time
Job Exempt
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