Takeda
Head RDQCS Compliance
Takeda, Boston, Massachusetts, us, 02298
Job Title : Head RDQCS Compliance
Location : Cambridge, MA
About the role:Leads the global R&D Quality Compliance organization, providing oversight of the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.
How you will contribute:
Responsible for the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation. Builds strategic plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities in coordination with R&D Quality leadership.
Leads the systematic application of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs. Responsible for authoring, editing, and circulating for approval the associated family of documents.
Owner of the RDQ Regulatory Intelligence program, reviewing, documenting and gap assessing global regulatory changes across all GxPs (GMP, GCP, GDP, GLP, PV) used within R&D/R&D Quality to ensure continued compliance with current global regulations.
Accountable for strategic oversight of the application of the gap assessment process, ensuring consistency of approach and compliance to SOPs. Responsible for identifying and executing on process improvements that are identified associated with the process.
Leads the R&D Quality Compliance team in stewardship of the R&D Quality Management System, ensuring R&D and R&D Quality remain in compliance with Global GxP regulations.
Leads representatives from across R&D/R&D Quality those who serve as system owners for centrally accessed QMS processes Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge. Works with system owners to develop metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.
Define, lead, and implement critical projects which enhance RDQ’s efficiencies and innovation. Engage in global, enterprise-wide cross-functional project and programs on behalf of RDQ to serve key business partners in R&D/R&D Quality.
Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations. Escalates issues and incidents with regulatory authorities in coordination with R&D and R&D Quality leadership.
What you bring to Takeda:
Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.
Minimum of 10 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance.
Six sigma/lean processing, project management professional and/or auditor certification preferred.
Important ConsiderationsAt 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:
May be required to wear personal protective equipment (PPE) and other clean room garments daily.
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.
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.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt : Yes
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Location : Cambridge, MA
About the role:Leads the global R&D Quality Compliance organization, providing oversight of the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.
How you will contribute:
Responsible for the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation. Builds strategic plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities in coordination with R&D Quality leadership.
Leads the systematic application of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs. Responsible for authoring, editing, and circulating for approval the associated family of documents.
Owner of the RDQ Regulatory Intelligence program, reviewing, documenting and gap assessing global regulatory changes across all GxPs (GMP, GCP, GDP, GLP, PV) used within R&D/R&D Quality to ensure continued compliance with current global regulations.
Accountable for strategic oversight of the application of the gap assessment process, ensuring consistency of approach and compliance to SOPs. Responsible for identifying and executing on process improvements that are identified associated with the process.
Leads the R&D Quality Compliance team in stewardship of the R&D Quality Management System, ensuring R&D and R&D Quality remain in compliance with Global GxP regulations.
Leads representatives from across R&D/R&D Quality those who serve as system owners for centrally accessed QMS processes Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge. Works with system owners to develop metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.
Define, lead, and implement critical projects which enhance RDQ’s efficiencies and innovation. Engage in global, enterprise-wide cross-functional project and programs on behalf of RDQ to serve key business partners in R&D/R&D Quality.
Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations. Escalates issues and incidents with regulatory authorities in coordination with R&D and R&D Quality leadership.
What you bring to Takeda:
Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.
Minimum of 10 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance.
Six sigma/lean processing, project management professional and/or auditor certification preferred.
Important ConsiderationsAt 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:
May be required to wear personal protective equipment (PPE) and other clean room garments daily.
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.
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.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt : Yes
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