Takeda Digital Ventures
Compliance Operations Lead, Associate Director (Hybrid)
Takeda Digital Ventures, Boston, Massachusetts, us, 02298
Compliance Operations Lead, Associate Director (Hybrid) Join to apply for the
Compliance Operations Lead, Associate Director (Hybrid)
role at
Takeda Digital Ventures . At Takeda, quality has always been a priority. Our Global Quality system encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines, and BioLife Plasma collection. Join us to make a meaningful impact on patients' lives. Job Details
Job ID:
R0160003 Date posted:
08/05/2025 Location:
Boston, Massachusetts Job Description
Objectives: Embed and implement global and R&D quality processes across CPMQ. Partner with teams to assess needs for process and system enhancements. Develop internal processes and training aligned with global standards and regulations. Lead change management initiatives for processes and systems. Monitor QMS health, identify risks, and implement mitigation plans. Foster a culture of continuous improvement and learning. Lead continuous improvement projects for clinical and safety quality compliance. Advise and support CPMQ on compliance activities. Collaborate with Global Quality and R&D Quality teams on enterprise solutions. Accountabilities: Create streamlined processes and tools for CPMQ activities, ensuring compliance with regulations. Design and deliver training on processes and systems. Manage change management plans for new or revised processes. Oversee the CPMQ training curriculum. Analyze quality data for insights and risk mitigation. Maintain dashboards to monitor QMS health and compliance metrics. Organize and manage Clinical and Pharmacovigilance Quality council meetings. Evaluate and escalate risks as needed. Implement lessons learned frameworks. Guide CPMQ on compliance activities and inspections. Present QMS insights to stakeholders. Represent CPMQ in global quality initiatives. Embed best practices and evaluate process improvements. Act as Steward of the QMS within CPMQ. Qualifications: BSc in a scientific or health-related field. At least 7 years in the pharmaceutical industry with 3+ in GCP Quality/Compliance. Deep knowledge of pharmaceutical development and regulations (FDA, EU, MHRA, PMDA, ICH). Experience in audit programs, regulatory inspections, investigations, and remediation. Proven ability to manage compliance issues and organizational change. Excellent communication and critical thinking skills. Fluency in English; additional languages are a plus. Additional Information: Physical demands are typical of an office environment. Willingness to travel internationally as needed. Compensation & Benefits: Base salary range: $153,600 - $241,340, depending on experience and location. Benefits include incentives, insurance, 401(k), paid time off, and more. Equal Opportunity:
Takeda is committed to diversity and equal employment opportunities. Location: Boston, MA. Employment type: Full-time, Exempt.
The following information aims to provide potential candidates with a better understanding of the requirements for this role. #J-18808-Ljbffr Remote working/work at home options are available for this role.
Compliance Operations Lead, Associate Director (Hybrid)
role at
Takeda Digital Ventures . At Takeda, quality has always been a priority. Our Global Quality system encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines, and BioLife Plasma collection. Join us to make a meaningful impact on patients' lives. Job Details
Job ID:
R0160003 Date posted:
08/05/2025 Location:
Boston, Massachusetts Job Description
Objectives: Embed and implement global and R&D quality processes across CPMQ. Partner with teams to assess needs for process and system enhancements. Develop internal processes and training aligned with global standards and regulations. Lead change management initiatives for processes and systems. Monitor QMS health, identify risks, and implement mitigation plans. Foster a culture of continuous improvement and learning. Lead continuous improvement projects for clinical and safety quality compliance. Advise and support CPMQ on compliance activities. Collaborate with Global Quality and R&D Quality teams on enterprise solutions. Accountabilities: Create streamlined processes and tools for CPMQ activities, ensuring compliance with regulations. Design and deliver training on processes and systems. Manage change management plans for new or revised processes. Oversee the CPMQ training curriculum. Analyze quality data for insights and risk mitigation. Maintain dashboards to monitor QMS health and compliance metrics. Organize and manage Clinical and Pharmacovigilance Quality council meetings. Evaluate and escalate risks as needed. Implement lessons learned frameworks. Guide CPMQ on compliance activities and inspections. Present QMS insights to stakeholders. Represent CPMQ in global quality initiatives. Embed best practices and evaluate process improvements. Act as Steward of the QMS within CPMQ. Qualifications: BSc in a scientific or health-related field. At least 7 years in the pharmaceutical industry with 3+ in GCP Quality/Compliance. Deep knowledge of pharmaceutical development and regulations (FDA, EU, MHRA, PMDA, ICH). Experience in audit programs, regulatory inspections, investigations, and remediation. Proven ability to manage compliance issues and organizational change. Excellent communication and critical thinking skills. Fluency in English; additional languages are a plus. Additional Information: Physical demands are typical of an office environment. Willingness to travel internationally as needed. Compensation & Benefits: Base salary range: $153,600 - $241,340, depending on experience and location. Benefits include incentives, insurance, 401(k), paid time off, and more. Equal Opportunity:
Takeda is committed to diversity and equal employment opportunities. Location: Boston, MA. Employment type: Full-time, Exempt.
The following information aims to provide potential candidates with a better understanding of the requirements for this role. #J-18808-Ljbffr Remote working/work at home options are available for this role.