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Job Description

Job Title: Sr. Quality Assurance Compliance Specialist

Location: Lexington, MA (USA)

About the role:

In this position, you will lead corporate inspections and help manage external inspections, the compliance program, and other QRC functions. You will manage the Top Compliance gaps and risks and providing support to mitigate them. This is a hybrid position, and you will report to the Associate Director Compliance and Supplier Quality.

How you will contribute:

• You will lead corporate inspections and support external health authority inspection activities. You will develop and prepare the site audits by holding audit readiness meetings, conduct role plays, review investigations, and partner with quality, manufacturing, and other supporting teams.
• You will author written responses to internal and external inspections. You will conduct assessment of internal quality systems and other areas, using applicable quality manual, quality standards, global and local procedures, applicable country regulations, directives, inspection guidelines and compendia to ensure the site is in compliance.
• You will assure regulatory citations received by other facilities or other cascades are shared to appropriate management teams for review and evaluation for site impact and remediation.
• You will track/trend action plans provide compliance expertise and oversee closure of commitments.
• You will prepare slides for key quality indicators and metrics supporting Quality Council and support Global Key performance indicator reporting.
• You will develop GMP related training programs within specified guidelines around compliance topics and inspection readiness.

What you will bring to Takeda

Bachelor's degree in science, engineering, or another related technical field required

3-5 years of regulatory/audit experience in a Pharmeceutical or Biotechnology field required

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.

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.

This posting excludes Colorado applicants.

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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.

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