Senior Global Quality Auditor

Role Summary

Senior Global Quality Auditor. The Sr. Principal Associate - Quality Auditor provides quality assurance through internal and external audits across pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance and consumer information quality (CIQ) to ensure GXP operations comply with company standards and regulatory requirements.

Responsibilities

• Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, internal and external (contracted) to assess compliance with standards, policies, practices and current regulations; lead or solo auditor as appropriate.
• Participate in mock-inspections, as appropriate.
• Participate or lead risk assessments of research and commercial operations; integrate findings to influence actions across GQAAC and involved business areas.
• Drive escalation of compliance issues or significant risks identified during audits or risk assessments.
• Meet requirements outlined in quality standards, manuals, policies, procedures, and tools.
• Identify the need to revise GQAAC quality system documents; participate or lead preparation/review of standards, policies, procedures and guidelines.
• Participate or lead preparation of organizational metrics and trending of audit findings.
• Provide advice on interpretation of corporate and regulatory GXP requirements; establish and maintain relationships with regulatory authorities; support regulatory inspections when required.
• Provide technical expertise in quality and compliance education to customers as required; influence internal and external customers on improvements.
• Participate in continuous improvement related to the role; represent assigned process in change initiatives; drive innovation to simplify and standardize audit processes.
• Support implementation of management/lead team strategies and improvements.

Qualifications

• Minimum: Bachelor’s Degree; preferred in physical or biological sciences or other technical area.
• Minimum five (5) years' experience related to Pharmacovigilance (PV) or pharmaceutical industry.

Skills

• Ability to analyze detailed technical information and assess risk and impact; articulate risk to senior management and quality organizations.
• Interpret and apply regulations, regulatory guidance, codes and public expectations; recommend compliance changes as appropriate.
• Excellent interpersonal and communication skills (oral and written); deliver professional communications at all levels.
• Global team experience; data management and computer proficiency.
• Strong analytical problem-solving skills; manage multiple complex projects in parallel.
• Systematic approach to safety and audit team well-being; project management capabilities.
• Ability to influence and manage change/conflict; think pragmatically and adapt to fast-paced environments.

Education

• Bachelors Degree - Preferred degree in physical or biological sciences, or other technical area.

Additional Requirements

• Domestic and international travel up to 40% (1-2 weeks), sometimes on short notice.