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

Takeda • Boston, MA

18d

About The Position

OBJECTIVES/PURPOSE: Advance strategic quality leadership by embedding global standards across Clinical, Pharmacovigilance, and Medical Quality (CPMQ), ensuring regulatory alignment and operational excellence. Drive innovation and transformation through organizational planning, digitalization, and capability building—enhancing systems, analytics, and process efficiency across CPMQ and R&D. Strengthen quality oversight and risk management, leading compliance strategies, monitoring systems, and continuous improvement initiatives that mitigate systemic risks and foster resilience. Serve as a strategic partner and change agent, shaping clinical trial delivery transformations, guiding GCP strategy, and aligning quality initiatives with enterprise priorities and a culture of learning.

Requirements

• A BSc/BA degree. A degree in scientific or allied health/medical field preferred.
• Minimum of 5 years of relevant experience. Experience can range from pharmaceutical R&D to project management, strategy and innovation in a regulated environment.
• 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.

Nice To Haves

• An advanced degree on strategy, innovation and leadership is an advantage.
• Strong foundational knowledge of quality and compliance is an advantage.

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.

Benefits

• U.S. based employees may be eligible to participate in 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, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees