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Job Description

Job Title: Manager Quality Assurance Operations

Location: Lexington (USA)

About the role:

Responsibilities include:

In this role, you will execute leadership of QA Technical personnel providing oversight for Quality Systems, including deviations, CAPAs, and change controls associated with production activities at the Lexington location within MA Bio Ops. This includes objectives, performance review, skills development, and mentoring. This is a hybrid role, and you will report to the Head of Quality.

How you will contribute:

• You will provide partnership for Annual Product Reviews through authoring and review of relevant content.
• You will provide input for decisions related to intermediate and bulk drug substance disposition and release.
• You will partner with QA Floor Support team to ensure communication across the QA organization and provide on-the-floor oversight for key events (ie. swarming and investigation of events).
• You will partner with site Quality Management Systems to monitor policies, processes, procedures, and controls to ensure that the quality of products conform to established Takeda standards and agency regulations.
• You will support review and approval of Quality Systems such as deviations and change controls.
• You will uphold data integrity and GxP standards across the Quality and Manufacturing organization.
• You will partner with other groups responsible for Documentation, Validation, Floor Support, Investigations, Project Management, Reliability, Facilities & Maintenance, Scheduling, Tech Transfer, Raw Materials, and Disposition.
• You will support inspection-related activities, including gap assessments, risk assessments, remediation activities within sphere of influence.
• You will direct support of site inspections through SMEs as well as personnel for logistics of the inspection.
• You will report on agreed upon metrics and attend Visual Tier boards as appropriate.
• You will drive a continuous improvement mindset within the QA Technical team by purposeful, critical assessment of QA processes and improvement identification, support CI activities within the larger MA Bio Ops site.
• You will adhere to Takeda Values and apply to decision making and activities.
• You will foster an inclusive environment where all employees are welcomed, empowered and inspired to use their unique voices and talents.

What you Bring to Takeda

• Bachelor’s degree in science, engineering, or another technical field.
• 7+ years experience in a GMP setting associated with Quality or Manufacturing.
• 5+ years experience leading direct reports
• Knowledge and demonstrated experience in FDA and EMEA regulations including GMPs, quality systems and product disposition.

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.

#GMSGQ

#ZR1

#LI-Hybrid

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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time