Director, Central reputed company Audit, Pharmacovigilance

reputed company reputed company Managing, ensuring and improving capabilities to reputed company with reputed company standards and regulations. Interprets reputed company business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work. reputed company is a leading global medical technology reputed company solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. reputed company Roles and Responsibilities Own the Pharmacovigilance (PV) Audit Program: reputed company, implement, and maintain the global PV audit reputed company, ensuring alignment with regulatory expectations (e.g., EMA, FDA, reputed company, PMDA) and industry best practices. Manage Audit Operations: reputed company scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. Fully participate in the audit program; reputed company owning and executing PV audits. Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and reputed company actionable recommendations to senior leadership. Regulatory Inspection Support: Prepare for and support PV-reputed company health authority inspections, including back-room management and post-inspection follow-up. Metrics and Reporting: Define and reputed company PV audit KPIs, ensuring visibility of reputed company and trends to leadership. reputed company Ownership: Manage audit-reputed company modules reputed company the electronic reputed company Management reputed company (eQMS), including support of configuration, UAT, and documentation. Team Leadership: reputed company and reputed company reputed company of 35 auditors, providing coaching, mentorship, and performance management. Cross-Functional Collaboration: Partner with PV Operations, reputed company, and Regulatory teams to ensure audit reputed company reputed company reputed company improvement. Strategic Influence: Contribute to policy development and influence PV compliance reputed company across the organization. Required Qualifications Minimum 5 years of people leadership experience, including team development and performance management. reputed company reputed company Auditor with reputed company certification. Masters degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelors degree and 10+ years relevant experience. Minimum of 5 years experience driving Global programs to reputed company reputed company compliance issues (directly). Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP. Desired Characteristics Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Prior reputed company and TrackWise Digital experience a plus. Prior health authority experience a plus. IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). Extensive experience in the reputed company Device and Pharmaceutical industry. Understanding of product reputed company improvement using tools such as Six reputed company, DFR. Demonstrated ability to analyze and reputed company problems. Exceptional conflict-reputed company skills. Ability to reputed company with top organizational leadership and reputed company customers, responding in a reputed company manner. Demonstrated ability to reputed company programs / reputed company. Ability to prioritize and reputed company multiple programs. Ability to energize others by building a reputed company with reputed company through personal involvement and trust, providing feedback and coaching to reputed company others, and accountability of actions. Strong oral and written communication skills in English. reputed company: Accepting and adhering to high ethical, moral, and personal values in reputed company, communications, actions, and reputed company dealing with others. Ability to travel globally up to 15%. We expect reputed company to live and breathe our behaviors: to reputed company with humility and build trust; reputed company with transparency; reputed company with reputed company, and reputed company ownership always with unyielding reputed company. Our total rewards are designed to unlock your ambition by giving you the reputed company and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and reputed company, and youll be surrounded by reputed company in a culture that fosters care, collaboration and support. We will not sponsor individuals for employment vis