Quality Compliance Manager at Shire Human Genetic Therapies, Inc. in Lexington, Massachusetts

Job Description:

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Job Description

How You Will Contribute:

• You will train and prepare the site to step inspection management teams


• You will contribute to the comprehensive inspection readiness program


• You will integrate cross-functional stakeholder organizations into the inspection readiness infrastructure


• You will manage post audit/inspection response writing, approval and submission to Takeda Partners and Regulatory Authorities ensuring any impact to the operation is understood and taken into consideration concerning the criticality of the findings


• Ensuring adequate integration of regulatory commitments into the appropriate Quality Management System processes to sustain commitment adherence


• You will compile and maintain evidence-based documents for subsequent verification of prior regulatory commitments


• You will execute site internal audits in the role of lead auditor for multiple audits across MA Bio Ops site, and Corporate Operations, ensuring that regulatory requirements and expectations are adequately interpreted and implemented across all phases of the product life cycle

• Bachelor's Degree in Science


• 2+ years of management or leadership experience within biopharmaceutical manufacturing


• Experience with global cGMP regulations


• Experience working with regulatory agencies such as FDA


• Risk management experience

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, paid time off for vacation, sick leave, and volunteering


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional development opportunities


• Tuition reimbursement

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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 and work in a cold, wet environment.


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

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 position is classified as "hybrid" following Takeda's Hybrid and Remote Work policy. Schedule will be defined in office with manager.

The CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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.

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