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

Role Summary

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

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. Experience can range from pharmaceutical R&D to project management, strategy and innovation in a regulated environment.
• A BSc/BA degree. A degree in scientific or allied health/medical field preferred. An advanced degree on strategy, innovation and leadership is an advantage.
• Strong foundational knowledge of quality and compliance is an advantage.
• Adaptive thinking and a strong, critical mindset.
• Strong business acumen and presentation skills.
• Highly proficient at project planning, budgeting, and oversight.
• Strategic, motivated, forward-thinking and adaptable to dynamic situations.
• A solid understanding of innovation and how it should be applied in business.
• Excellent interpersonal, leadership, and communication skills.
• Has a track record of successful high-level interventions and projects which have resulted in long-term competitiveness within their organizations.

Skills

• Quality and compliance knowledge
• Strategic planning and transformation leadership
• Digitalization, analytics, and AI initiative experience
• Change management and stakeholder engagement
• GCP/GVP inspection support and quality council facilitation
• Budgeting, forecasting, and resource planning
• Communication and collaboration across cross-functional teams

Education

• BSc/BA in a scientific or allied health/medical field; advanced degree in strategy, innovation and leadership is a plus.

Additional Requirements

• Location: Boston, MA
• Full-time, Regular, Exempt