Director, Central Quality Audit, Pharmacovigilance

Accountabilities:
As the Director, Central Quality Audit, Pharmacovigilance , you will lead global audit activities and ensure compliance with regulatory expectations and industry standards. You will provide strategic direction, oversee audit operations, and develop quality processes that strengthen pharmacovigilance capabilities across the organization. Develop, implement, and maintain a global pharmacovigilance audit strategy aligned with regulatory requirements and industry best practices. Own and execute audit programs, including planning, scheduling, conducting, reporting, and follow-up activities for internal audits, affiliates, and service providers. Identify compliance risks, evaluate audit findings, escalate critical issues, and provide actionable recommendations to senior leadership. Support regulatory inspections by coordinating preparation activities, inspection responses, and post-inspection corrective actions. Define and monitor audit performance indicators, providing visibility into compliance trends and quality risks. Manage audit-related processes and systems within electronic Quality Management Systems (eQMS), including configuration support, testing, and documentation. Lead, coach, and develop a team of auditors, promoting professional growth, accountability, and operational excellence. Partner with Pharmacovigilance, Quality, Regulatory, and other stakeholders to ensure audit outcomes drive continuous improvement. Contribute to the development of quality policies and influence global compliance strategies. Lead improvement initiatives using structured problem-solving approaches and quality methodologies. Requirements: The ideal candidate brings extensive experience in pharmacovigilance quality, audit leadership, and regulated healthcare environments. This role requires strong strategic thinking, regulatory knowledge, leadership capabilities, and the ability to collaborate effectively with global stakeholders. Minimum of 5 years of experience leading teams, including coaching, mentoring, and performance management responsibilities. Active certification as a qualified Lead Auditor. Master’s degree with 5+ years of experience in pharmacovigilance or pharmaceutical industries, or Bachelor’s degree with 10+ years of relevant experience. Proven experience managing global programs focused on resolving quality and compliance challenges. Strong knowledge of pharmaceutical Quality Management Systems and regulatory requirements, including cGMP, GDP, GPvP, GCP, and GLP. Experience with medical device quality systems and regulations such as FDA CFR 21 820 and ISO 13485 is a plus. Familiarity with electronic quality systems such as Veeva and TrackWise Digital is desirable. Experience supporting health authority inspections is highly valued. Knowledge of quality improvement methodologies such as Six Sigma, Lean, or similar frameworks is beneficial. Strong analytical, problem-solving, and decision-making skills. Excellent communication, negotiation, and conflict-resolution abilities. Ability to influence senior leaders and manage complex global initiatives. Strong written and verbal English communication skills. Willingness to travel globally up to 15%. Benefits: Competitive salary range aligned with experience, skills, qualifications, and location. Performance-based incentive opportunities, including potential bonuses and long-term incentives. Comprehensive healthcare benefits, including medical, dental, and vision coverage. Retirement savings plan with employee and company contribution opportunities. Paid time off and additional employee support programs. Life, disability, and accident insurance coverage. Tuition reimbursement and professional development opportunities. Access to career growth opportunities within a global healthcare technology environment. Flexible work environment designed to support collaboration, innovation, and work-life balance.

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