Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions

Takeda

Pharmaceutical Industry

Zürich - Schweiz

Vice President

Hybrid

Experteer Overview

In this role you will provide oversight of clinical research and pharmacovigilance within post-authorization activities, contributing to a global quality framework. You will align R&D, business units, affiliates, and Quality to ensure compliant, agile operations. You will engage cross-functionally to translate scientific insights into robust quality programs and risk-based audits. The opportunity centers on shaping the post-authorization landscape through evidence-driven quality governance and collaboration.

Compensation / Benefits

base salary with incentives
medical, dental, vision insurance
401(k) with company match
tuition reimbursement
paid time off and holidays
well-being benefits

Responsibilities

Provide clinical research and pharmacovigilance regulatory interpretation and recommendations to business units and affiliates
Contribute to risk-based audit strategies across Global Quality, supporting supplier and internal audits
Lead high- to medium-severity quality investigations in CR and PV areas, coordinating with R&D and CPMQ
Support inspections and communicate risks within Global Portfolio Division and Global Quality
Contribute to KPIs and metrics relevant to CR and PV risks impacting MAHs and overall governance
Drive and sustain a global quality framework enabling compliant and agile CR and PV activities (e.g., evidence generation, patient access programs, RWE/RWD)
Engage with senior leaders across Quality, R&D, and Commercial to ensure post-authorization strategies are understood and implemented
Analyze post-authorization and commercial perspectives using CPMQ data trends and share insights with stakeholders

Key requirements

BSc in a scientific or allied health/medical field
Minimum 10 years in global pharmaceutical industry with at least 3 years in Quality/Compliance
Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations
Experience in cross-functional and enterprise collaborations between R&D and Commercial
Experience working in complex organizations and with executive-level colleagues
Excellent communication skills (public speaking, writing, interpersonal) and strong active listening
Strong critical thinking, problem-solving, and independent initiative
Demonstrated leadership and ability to foster open dialogue and drive results
Fluency in written and spoken English; additional languages are a plus
MBA or Quality Assurance certification advantageous
Willingness to travel up to ~10%

communication active listening leadership regulatory interpretation of CR and PV quality governance and audits risk-based audit planning

Description

In this role you will provide oversight of clinical research and pharmacovigilance within post-authorization activities, contributing to a g…

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