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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:

1) Audit Readiness and Regulatory Compliance operations:

Lead the site audit readiness plan, including Gemba walks, gap assessments, and SME preparation and logistics to ensure successful Internal and External inspections and logistics, such as holding audit readiness meetings.

Assist with authoring written responses to internal and external inspections.

Perform Gap assessment 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.

2) Self-Inspection Audits and Risk Management:

Lead and perform planned self-inspection audits to ensure compliance with regulatory requirements and company policies, Directives, inspection guidelines, compendia, and regulatory citations received by other facilities to ensure site compliance.

Lead and manage risks identified and included in the Risk Register, such as identifying risks for categorization and escalation and implementing adequate preventative measures using formal QRM tools.

Responsible to perform Observation Review Process gap assessment and drive actions resulting from the evaluation.

3) Quality Council; Site Master File and Annual Product Reviews: Data Compilation Review and Analysis:

Lead and support efforts of the annual Product Quality Review. Responsible for leading efforts to collect data and authoring the reports on time, and Support digital project and site implementation.

Perform Technical Review and analysis of statistical data for key quality indicators and metrics during the Quality Council to drive mitigation action and improvements.

Support the preparation of quality compliance metrics for SISR, and to support local and global Quality Councils and digital project and site implementation.

Support the maintenance and technical review of the Site Master File updates.

4) GMP Support and Task Management

Provide NEO training to new employees on GMP regulations and compliance. Develops GMP-related training programs within specific guidelines

License Renewal: Supporting documentation Management from Regulatory Bodies and internal customers

Regulatory Trends Knowledge: Partner with the 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 as needed for external, corporate, and customer audits and Risk Management processes.

Quality Goals Achievement: Manage self-activities to achieve defined quality goals efficiently, accurately, and on time.

Serves as a resource within the plant. Interacts frequently with functional peers and senior group managers—acts as a consultant to benchmark with other facilities, as requested.

5) Project management:

Manage self-activities to achieve defined quality goals efficiently, accurately, and on time.

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 to comply with internal and external quality and customer requirements.

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.

6) Communication and Issue Reporting:

Notify management of potential issues that could jeopardize the effective release of acceptable products to internal and external customers.

7) 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. Strong knowledge of cGMP (US, EU, China, etc.) is required. Specifics include 21 CFR parts 201, 211, 600, 601, and 606 series and the Eudralex.

Thorough knowledge of applicable procedures, specifications and quality standards. . Knowledge of USP and EP. Sounds knowledge of manufacturing and laboratory operations within a Pharmaceutical/ biopharmaceutical industry.

Excellent Data analytical, critical thinking, risk management, continuous improvement, organizational, communication, and project management skills.

Proficiency in using quality management software and Digital tools (e.g. Visio, Microsoft Applications (Share point, Microsoft Project, Word, Excel, PowerPoint,).

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.

Exhibit Takeda Leadership Behaviors and Values:  Be proactive, foster trust, cultivating relationships, Communicate with Impact, Cultivate Relationships, embrace diversity, Encourage Teamwork, Deliver on Commitments, Execute Plans, ensure accountability, Know Our Business, Propose Solutions, Clarify what matters most, Demonstrate Flexibility, Promote Change, Lead Continuous Improvement, Be Conscientious, Be Open and receptive, Enhance Personal Leadership and Take initiative.

What you bring to Takeda:

Required: Typically requires bachelor’s degree in science, engineering or other related technical field. 3+ years of related experience. Bachelor’s degree in chemistry or Biological Science is preferred. 

Strong knowledge of regulatory requirements and quality standards.

Desired: Strong knowledge of regulatory requirements and quality standards.

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 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 multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

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

May be required to work in a confined area.

Some Clean Room and cool/hot storage conditions.

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:

USA - CA - Los Angeles

U.S. Base Salary Range:

84,000.00 - 132,000.00

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.

LocationsUSA - CA - Los Angeles

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes