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. The role drives a global, fit-for-use Quality framework and supports post-authorization strategies through partnerships across R&D, business units, affiliates, and Global Quality. It focuses on elevating capabilities, ensuring high compliance and agility in 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 plans consider clinical research and pharmacovigilance activities in risk-based audit strategies; participate in audit planning and mitigate identified risks with responsible partners in Global Portfolio Division, R&D, and Quality.
• Provide input on high to medium and potential systemic quality investigations in the clinical research and pharmacovigilance areas; liaise with relevant R&D functions and CPMQ personnel; escalate critical non-compliance or lack of remediation urgency to Senior Management.
• Support inspections to ensure risks are communicated within the GPD and Global Quality organizations.
• Contribute to Global Quality governance with fit-for-purpose KPIs and metrics relevant to clinical research and pharmacovigilance risks affecting MAHs; analyze and communicate risks within GPD and Global Quality.
• 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 global Quality framework that elevates capabilities of business units and affiliates to deliver regulated activities (including evidence generation studies, patient access programs, IIR, collaborative research, RWE/RWD) with high compliance and agility; champion proactive and innovative approaches with Quality and business leaders.

Qualifications

• Required: BSc in a scientific or allied health/medical field (or equivalent).
• Required: Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 3 years in Quality/Compliance.
• Required: Advanced knowledge of clinical research, medical affairs activities and pharmaceutical commercial operations.
• Required: Experience with cross-functional and enterprise collaborations, particularly between R&D and Commercial; ability to work within complex organizations with senior staff.
• Required: Excellent communication and listening skills, strong collaboration and relationship-building capabilities; ability to translate complex issues clearly.
• Required: Demonstrated leadership, judgment, independent initiative, and ability to develop and support employees’ growth.
• Required: Fluency in written and spoken English; additional language skills are a plus.
• Preferred: MBA or Quality Assurance certification (e.g., Lean Six Sigma).

Skills

• Strategic thinking and problem solving
• Cross-functional collaboration and stakeholder management
• Effective communication (written and verbal) at executive levels
• Quality governance and risk management
• Data interpretation and trend analysis

Education

• Bachelor’s degree in a scientific or allied health/medical field (or equivalent).

Additional Requirements

• Travel: Willingness to travel to various meetings, including overnight trips; some international travel may be required (approximately 10%).