Quality Compliance Analyst II

Job Title: Quality Compliance Analyst II

Location: Thousand Oaks, CA

About the Role:

As a Quality Compliance Analyst II, you will play a key role in supporting inspections, leading GMP compliance initiatives, and completing investigations and assessments. This is an on site role that reports to the Quality Compliance Manager.

How you will contribute:

• You will Support external regulatory inspections and local inspection readiness efforts and serve as a Quality Council Coordinator, Product Complaint Evaluator, and Gap Assessment Coordinator.

• You will act as Lead Auditor for self-inspections and supplier audits.

• You will coordinate efforts associated with GMP re-certification and product licensing.

• You will lead or participate in efforts to mitigate facility compliance risks in GxP. Provide consultation, support, and guidance regarding GxP compliance concerns and serve as a plant resource for compliance to these requirements.

• Participate in local GMP walkthroughs and may present information during an inspection as a subject matter expert.

• Complete corrective actions on-time, support quality incidents and risk register

• Participate or lead continuous improvement teams (e.g. DMAIC, Lean, Kaizen), improving quality and compliance.

• Actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation.

• Complete Quality Systems responsibilities and other duties as assigned

What you bring to Takeda:

• Bachelor's degree in science or engineering strongly preferred.

• Minimum 3 years' industry experience.

• Experience with quality auditing or process improvement would be ideal.

• Functional knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations.

• You will effectively interface with higher levels of management across all functional areas at the site and possess courage of conviction to maintain/improve site compliance.

• Good project management skills.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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:

• 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.

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

• Work in a cold, wet environment.

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

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

• Overall physical exertion is mostly sedentary with light physical work.

• Able to work in controlled or clean room environments requiring special gowning.

• May be required to work overtime or be assigned to a different shift.

• Will interact with other people; pace may be fast and job completion demands may be high.

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 - Thousand Oaks - Rancho Conejo

U.S. Hourly Wage Range:

$27.60 - $43.37

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based e mployee s may be eligible for s hort - t erm 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.

Locations USA - CA - Thousand Oaks - Rancho Conejo Worker Type Employee Worker Sub-Type Regular Time Type Full time

Job Exempt

No