Assoc Dir, Clinical Pharmacovigilance and Medical Quality (CPMQ) Operations

Role Summary

Assoc Dir, Clinical Pharmacovigilance and Medical Quality (CPMQ) Operations

Role focuses on advancing strategic quality leadership across Clinical, Pharmacovigilance, and Medical Quality (CPMQ), driving digital transformation, and strengthening quality oversight and risk management. Serves as a strategic partner to shape clinical trial delivery, GCP strategy, and enterprise-quality alignment.

Responsibilities

• Identify and lead innovative transformation initiatives across CPMQ, aligning with Takeda R&D and Global Quality objectives.
• Develop and execute strategic plans that enhance operational efficiency, connectivity, and digitalization across CPMQ and its stakeholders.
• Monitor CPMQ KPIs and performance trends, intervening as needed and guiding future planning.
• Design and implement simplified, end-to-end functional processes and tools aligned with global standards.
• Lead training development and delivery to support process and system implementation across CPMQ.
• Create and manage change management plans for new and revised CPMQ processes and systems.
• Analyze quality data to identify compliance risks, maintain QMS dashboards, and drive mitigation strategies.
• Organize and facilitate Clinical and Pharmacovigilance Quality council meetings, including agenda and communications.
• Oversee CPMQ Risk Register and Quality Investigations, escalating systemic risks and trends.
• Promote knowledge management and lessons learned frameworks to foster continuous improvement.
• Provide expert guidance on quality compliance and embed best practices across CPMQ teams.
• Act as QMS steward, overseeing deviations, serious breaches, CAPAs, SOPs, audits, inspections, and training assignments.
• Provide support to GCP/GVP inspection activities, including backroom operations and issue escalation.
• Oversee GxP-related contracts and invoice approvals, ensuring alignment with quality standards.
• Drive digitalization and AI initiatives within CPMQ to enhance operational capabilities.
• Support CPMQ budget and resource planning in partnership with Finance, ensuring global initiative funding.
• Maintain CPMQ playbook and communication platforms to ensure stakeholder awareness and alignment.

Qualifications

• Minimum of 5 years of relevant experience in pharmaceutical R&D, project management, strategy, or innovation in a regulated environment.
• A BSc/BA degree; degree in scientific or allied health/medical field preferred. An advanced degree in strategy, innovation and leadership is an advantage.
• Strong foundational knowledge of quality and compliance; adaptive thinking and critical mindset.
• Strong business acumen and presentation skills; highly proficient in project planning, budgeting, and oversight.
• Strategic, motivated, forward-thinking and adaptable to dynamic situations; solid understanding of innovation in business.
• Excellent interpersonal, leadership, and communication skills; track record of high-impact interventions and projects.

Skills

• Quality and compliance fundamentals
• Strategic planning and organizational transformation
• Digitalization, analytics, and AI initiatives
• Change management and knowledge management
• Stakeholder engagement and cross-functional collaboration
• GCP/GVP inspection support and quality governance

Education

• BSc/BA required; advanced degree in strategy, innovation, or leadership is a plus.

Additional Requirements

• Location: Boston, MA
• Full-time, Employee
• U.S. base salary range: $153,600.00 - $241,340.00