Director of Pharmacovigilance Quality Assurance (Biotechnology, Remote)

Job summary

The role involves leading the Pharmacovigilance Quality Assurance (PV QA) function, focusing on compliance with Good Pharmacovigilance Practices (GVP) and European regulatory requirements. The Director will oversee quality audits, lead inspection activities, and mentor team members to enhance the overall competency of the global R&D QA team.

Qualifications

• Master's or Bachelor's degree in Natural Science or a related field.
• Over 15 years of experience in a PV Quality function with proven leadership experience.
• Experienced Lead Auditor with deep expertise in GVP processes and European requirements.
• Strong understanding of safety aspects related to clinical trials and regulatory expectations.

Responsibilities

• Plan, perform, and report on quality audits within GVP regulated areas.
• Lead PV inspection activities for regulatory bodies such as FDA, EMA, or PMDA.
• Provide leadership and oversight of PV QA to ensure timely and compliant deliverables.
• Mentor and onboard QA colleagues to improve team competency.
• Develop and maintain PV QA strategies in collaboration with leadership.
• Drive standardization and scalability of PV QA processes.
• Ensure compliance with global GxP standards and internal Quality Systems.
• Lead quality improvement initiatives and manage vendor qualifications.
• Review and contribute to Standard Operating Procedures (SOPs) and Quality Management System (QMS) documents.
• Develop training programs for internal and external stakeholders.
• Monitor industry trends and regulatory updates to maintain quality standards.

Skills

• Strong leadership and collaboration skills in an international setting.
• Ability to educate and mentor team members effectively.
• Excellent problem-solving skills with a science-based approach.
• Strong communication skills for interaction with various stakeholders.

Education

• MS or BS in Natural Science or a related field.

Tools

• Familiarity with quality management systems and regulatory compliance tools.