Takeda · 2 days ago
Assoc Director, Clinical and Safety Quality Compliance
Boston, MA
Full-time
Hybrid
Director/Executive
$154K/yr - $241K/yr
7+ years expTakeda is a global pharmaceutical company dedicated to providing better health and a brighter future. The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs, defining activities and standards, auditing processes, and ensuring compliance with regulatory standards.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by compliance to regulatory intelligence procedures
Ensures a robust communication plan is in place (including brief description of the new and or revised regulations the impact, any risks, mitigation plans, timelines) that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ. Communicates to CPMQ periodically the progress of new and revised regulations and impact
Ensure implementation of change control and actions completed to address new and revised regulations. Oversees the review, completion and closure of routine and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance-related change controls
Provides data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance risks, and proactively provides strategic and tactical directions in the mitigation
Actively participate and contribute to enterprise-wide projects and initiatives, ensuring insights related to clinical and safety quality are considered
Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively participate and represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO, PSPV, GRA etc. Review the outputs of the safety and clinical trial delivery redesigned processes and coordinate CPMQ colleague’s input
Provide CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit, etc.) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact of projects impacting clinical and safety quality
Actively identifies key areas for process improvements and develop and execute plans according to timelines. Support the implementation of new and revised processes across CPMQ
Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the Leadership Team
Qualification
Required
BSc in a scientific or allied health/medical field (or equivalent degree)
Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance
Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH
Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation activities on a global level
Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
Skilled in managing global, cross-functional projects
Successful management of business transformation/change management initiatives e.g. quality system integration, outsourcing strategy etc
Excellent communication skills to convey message
Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions
Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions
Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues
Fluency in written and spoken English, additional language skills a plus
Benefits
Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
Pharma Letter
2026-01-03
2025-12-30
Company data provided by crunchbase