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Job Title: Senior Quality Assurance Specialist II

Location: Lexington, MA

About the role:

As the Senior Quality Assurance Specialist, you will be accountable for disposition activities with the QA Disposition group supporting the Lexington Site. This is a hybrid role that will report to the QA Manager.

The scope of operations includes unpurified bulk (UPB) and drug substance (DS) disposition activities performed in support of manufacturing activities executed at the Lexington Site within the Biologics Operating Unit. You will manage the timely disposition of UPB and DS in line with global regulatory expectations and Shire standards. You will work with cross functional groups in each department supporting manufacturing operations within the Lexington Site organization. You will ensure consistency and communication across the manufacturing operating sites. You will partner with other QA groups, QC, Manufacturing, Compliance, Materials Management, Regulatory and Supply Chain to ensure timely disposition of intermediates and products.

Collaboration and the ability to work with cross functional groups are critical to success.

The scope of this role also includes management of quality systems from initiation to closure (deviations, investigations, CAPAs, change controls) that occur at Lexington site.

How you will contribute:

• Responsible for representing quality on complex investigations and multi-disciplinary teams as required
• Responsible for metrics around disposition
• Support regulatory submissions and inspections
• Responsible for SAP transactions relevant to disposition
• Actively work with PIER, MFG, QC and QA peers to support deviation, CAPA and Change Controls.
• Group metrics' tracking and compliance
• Responsible for presenting disposition metrics in various forums (i.e. QMR)
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs in a compliant manner
• Responsible for review of investigations and quality systems related to disposition of specific batches
• Collaborate with key stakeholders including but not limited to Supply Planning, Materials Management and Supplier Quality relative to raw material quality concerns and batch disposition planning
• Responsible for review of all criteria required for disposition of raw materials and products
• Accountable for meeting functional area goals and objectives as they related to disposition activities
• Responsible for support of batch disposition production data for Annual Product Quality Review

What you bring to Takeda:

• A minimum of 5 years in a cGMP biotech or pharmaceutical environment plus 3 years specific to disposition of UPB and DS.
• Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.
• BS with 10+ years relevant Quality experience

What Takeda can offer you:

• Tuition reimbursement
• Professional training and development opportunities
• Community Outreach Programs and company match of charitable contributions
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Generous time off for vacation and the option to purchase additional vacation days
• Health & Wellness programs including onsite flu shots and health screenings
• Comprehensive Healthcare: Medical, Dental, and Vision
• Family Planning Support

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. You may:

• Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• Some Clean Room and cool/hot storage conditions.
• Work multiple shifts, including weekends.
• May be required to work in a confined area.
• Will work in a cold and wet environment.
• Non-Exempt Roles only: Must be able to work overtime as required.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

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.

Locations

USA - MA - Lexington - BIO OPS

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time