Director, Central Quality Audit, Pharmacovigilance

This is a fully remote position, open to applicants in Norway.

📋 Description

• Take ownership of the Pharmacovigilance (PV) Audit Program by developing, implementing, and maintaining the global PV audit strategy, ensuring it aligns with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices.

• Oversee Audit Operations, which includes the scheduling, planning, execution, reporting, and follow-up of PV audits, covering both internal audits and those involving service providers and affiliates.

• Actively engage in the audit program by fully participating in and executing PV audits.

• Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership for effective risk communication.

• Support regulatory inspections by preparing for and managing PV-related health authority inspections, including back-room activities and follow-up after inspections.

• Define and monitor PV audit KPIs, ensuring leadership has visibility into compliance risks and trends.

• Manage audit-related modules within the electronic Quality Management System (eQMS), including support for configuration, user acceptance testing (UAT), and documentation.

• Lead and develop a team of 3–5 auditors by providing coaching, mentorship, and performance management.

• Collaborate cross-functionally with PV Operations, Quality, and Regulatory teams to ensure that audit outcomes promote continuous improvement.

• Influence strategic policy development and contribute to the PV compliance strategy across the organization.

⛳️ Requirements

• At least 5 years of experience in people leadership, including team development and performance management.

• Active certification as a Qualified Lead Auditor.

• A Master’s degree with 5+ years in pharmacovigilance or the pharmaceutical industry; or a Bachelor’s degree with over 10 years of relevant experience.

• Minimum of 5 years’ experience in driving global programs to address quality compliance issues directly.

• Familiarity with Pharmaceutical QMS and regulatory requirements, including but not limited to cGMP, GDP, GPvP, GCP, and GLP.

• Knowledge of Medical Device QMS requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.

• Experience with Veeva and TrackWise Digital is a plus.

• Previous experience with health authorities is an advantage.

• Additional certifications such as IRCA, ASQ (CQE, CQA, etc.), and/or Lean Certification (green belt, black belt) are a plus.

• Extensive experience in the Medical Device and Pharmaceutical industries.

• Understanding of product quality improvement methodologies, including tools like Six Sigma and DFR.

• Proven ability to analyze and resolve complex problems.

• Excellent conflict-resolution skills.

• Capability to interact with top organizational leadership and both internal and external customers in a professional manner.

• Demonstrated leadership in managing programs and projects.

• Ability to prioritize and manage multiple programs effectively.

• Strong oral and written communication skills in English.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid time off

• A 401(k) plan with opportunities for employee and company contributions

• Life insurance

• Disability insurance

• Accident insurance

• Tuition reimbursement