Director, Central Quality Audit, Pharmacovigilance
New
J
JobgetherPharmacovigilance, Healthcare
Based in United StatesFull-TimeDirector
SalaryCompetitive salary range aligned with experience, skills, qualifications, and location. Performance-based incentive opportunities, including potential bonuses and long-term incentives.
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Job Details
- Languages
- English
- Experience
- 5+ years with Master's degree or 10+ years with Bachelor's degree
- Required Skills
- GCP
Requirements
- 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.
- Minimum of 5 years of experience leading teams, including coaching, mentoring, and performance management.
- Proven experience managing global programs focused on quality and compliance challenges.
- Strong knowledge of pharmaceutical Quality Management Systems and regulatory requirements (cGMP, GDP, GPvP, GCP, GLP).
- Strong written and verbal English communication skills.
- Ability to influence senior leaders and manage complex global initiatives.
- Willingness to travel globally up to 15%.
- Familiarity with electronic quality systems such as Veeva and TrackWise Digital is desirable.
- Experience with medical device quality systems (FDA CFR 21 820, ISO 13485) is a plus.
- Knowledge of quality improvement methodologies (Six Sigma, Lean) is beneficial.
Responsibilities
- 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.
- 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).
- Lead, coach, and develop a team of auditors, promoting professional growth and operational excellence.
- Partner with Pharmacovigilance, Quality, and Regulatory stakeholders to ensure audit outcomes drive continuous improvement.
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