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

Role Summary

Associate Director, Clinical PV & Medical Quality, CPMQ Global Regions. Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business units and affiliates. Drives a fit-for-use global Quality framework to elevate capabilities and enable compliant, agile delivery of clinical research and pharmacovigilance activities.

Responsibilities

• Provide expertise in clinical research and pharmacovigilance regulations and compliance interpretation, consultation, and recommendations to relevant functions in the business units and affiliates.
• Ensure Global Quality Audit functions consider clinical research and pharmacovigilance activities in risk-based audit strategies and programs; participate in audit planning and mitigate identified risks with responsible partners in Global Portfolio Division, R&D, and Quality.
• Provide expert input in high to medium and/or potential systemic quality investigations in the clinical research and pharmacovigilance areas, liaising with relevant R&D functions and CPMQ personnel; escalate critical non-compliance issues to Senior Management.
• Support inspections and ensure risks are well-communicated within GPD and Global Quality organizations.
• Provide input to Global Quality on fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research and pharmacovigilance risks impacting MAHs; analyze and communicate risks within GPD and Global Quality; contribute to governance (e.g., Quality Council) for the business units and affiliates under GPD.
• Ensure post-authorization and commercial perspectives are analyzed using CPMQ data trends and insights; communicate trends to stakeholders in Global Portfolio Division and Global Quality.
• Drive a fit-for-use global Quality framework that elevates affiliate capabilities to deliver regulated activities (e.g., evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility; engage Quality and business leaders for collaboration.

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 10 years of increasing responsibility in the 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, particularly between R&D and Commercial.
• Experience in complex organizations, working with senior staff and executives.
• Excellent communication and active listening skills; ability to convey messages clearly and build win-win solutions.
• Strong critical thinking and problem-solving abilities; leadership and interpersonal skills with a collaborative style.
• Ability to translate complex issues succinctly and interact across all levels of the organization.
• Fluency in written and spoken English; additional languages a plus.

Education

• MBA or Quality Assurance certification (e.g., Lean Six Sigma) preferred

Travel Requirements

• Willingness to travel to various meetings, including overnight trips; some international travel may be required.
• Approximately 10% travel expected.