Pharmacovigilance Quality Assurance Manager

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Key Responsibilities

Auditing

• Independently leads the planning, conduct, and reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes in GxP/non-regulated environments to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
• Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
• Manages complex or business critical audits/issues in a supporting or leading role.
• Supports other auditors in planning, conduct and reporting of audits.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Supports the CAPA process following the audit as needed.
• Encourages and supports others to properly manage and document the risk-based approach in the audit planning and conduct.

Inspection Support

May participate in regulatory inspections in a leadership role (e.g. host, backroom lead).

Training & Development

• Identifies training needs.
• Supports development and provides training.
• Independently advises and coaches other auditors.
• Involved with the review and approval of curriculum as applicable.
• Completes training requirements in a timely manner to ensure inspection readiness at all times.

People Management

• Able to supervise junior auditors/contractors.
• Deputizes for Team Lead, as required.

Project Management

• Leads initiatives and actively participates in key projects across the organization or company.
• Interacts with key stakeholders and can influence and effectively drive projects to completion.

Expertise

• Actively shares business area and regulatory knowledge/expertise.
• May act as a primary contact for internal and/or external stakeholders.
• Conducts peer review of audit reports, as required.
• Independently provides consultation and advice to Business Partners on quality and compliance processes/procedures.
• Interprets and applies regulations/policies to unique and/or complex issues, when required.

Qualifications

Education: Minimum bachelor's or equivalent University degree required; focused degree in a life, natural, or computer science is preferred.

Experience and Skills: Required: A minimum of 6 years of relevant work experience in a GxP regulated industry including 3 years in pharmacovigilance auditing. Strong project management experience. Strong verbal and written skills, including presentation skills. Strong teamwork and analytical skills.

Preferred: Experience in leading complex pharmacovigilance audit types e.g., system audits.

Other: Must be fluent in English. This position requires 25% domestic and international travel.