Takeda
Manager, Cell Therapy Quality Compliance
Takeda, Boston, Massachusetts, us, 02298
Job Description
Job Title : Manager, Cell Therapy Quality Compliance Location : Cambridge, MA About the role:
The Manager, Cell Therapy Quality Compliance & Systems will focus on Compliance Systems requirements specific to internal cGMP manufacturing and testing of clinical-phase cell therapy programs. You will establish and maintain Quality Compliance governance and processes, and improving performance associated with Takeda’s internal cell therapies manufacturing facility. You will manage adherence to Quality Management System (QMS) requirements within the facility and directly manage the development of cGMP quality procedures for clinical-phase cell therapies. You will report to the Director, Cell Therapy Compliance. How you will contribute:
Manage review, gap assessment and implementation of global and local GMP documents (e.g., Standards, SOPs, Job Aids) to ensure seamless integration of the QMS. Lead evaluation of metrics and performance reporting as part of Quality Councils. Organize and analyze data and identify trends to offer solutions. Accountable for the effectiveness of local training program. Develop training material for local processes. Oversee facility records management and ensure compliance with company and regulatory requirements. Comply with data integrity requirements and ensure local procedures are aligned with global requirements. Be a key contact and local subject-matter expert for QMS systems (e.g. change control, deviation, CAPA). Investigate system failures and ensure successful resolution. Conduct training for new users. Apply systems knowledge to offer practical solutions and minimize compliance risk. Help with the preparation and review of incidents as part of the Quality Incident Management process. Manage internal quality improvement projects; evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs. Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance. Minimum Requirements/Qualifications:
Bachelor’s Degree in Chemistry, Biology, Engineering, or related field. Master’s preferred. 7+ years of experience in the biotech industry. 5+ years of Quality/cGMP Compliance experience. Specific experience in the following: Cell and/or gene therapy product manufacturing or testing. Investigational medicinal products. Experience working in an internal biopharmaceutical development 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. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time Job Exempt Yes
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Job Title : Manager, Cell Therapy Quality Compliance Location : Cambridge, MA About the role:
The Manager, Cell Therapy Quality Compliance & Systems will focus on Compliance Systems requirements specific to internal cGMP manufacturing and testing of clinical-phase cell therapy programs. You will establish and maintain Quality Compliance governance and processes, and improving performance associated with Takeda’s internal cell therapies manufacturing facility. You will manage adherence to Quality Management System (QMS) requirements within the facility and directly manage the development of cGMP quality procedures for clinical-phase cell therapies. You will report to the Director, Cell Therapy Compliance. How you will contribute:
Manage review, gap assessment and implementation of global and local GMP documents (e.g., Standards, SOPs, Job Aids) to ensure seamless integration of the QMS. Lead evaluation of metrics and performance reporting as part of Quality Councils. Organize and analyze data and identify trends to offer solutions. Accountable for the effectiveness of local training program. Develop training material for local processes. Oversee facility records management and ensure compliance with company and regulatory requirements. Comply with data integrity requirements and ensure local procedures are aligned with global requirements. Be a key contact and local subject-matter expert for QMS systems (e.g. change control, deviation, CAPA). Investigate system failures and ensure successful resolution. Conduct training for new users. Apply systems knowledge to offer practical solutions and minimize compliance risk. Help with the preparation and review of incidents as part of the Quality Incident Management process. Manage internal quality improvement projects; evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs. Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance. Minimum Requirements/Qualifications:
Bachelor’s Degree in Chemistry, Biology, Engineering, or related field. Master’s preferred. 7+ years of experience in the biotech industry. 5+ years of Quality/cGMP Compliance experience. Specific experience in the following: Cell and/or gene therapy product manufacturing or testing. Investigational medicinal products. Experience working in an internal biopharmaceutical development 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. Locations
Boston, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time Job Exempt Yes
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