Senior Auditor Enterprise Quality Auditing

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Quality Auditor

About the Opportunity

We are seeking a skilled and independent professional to join our Quality team as a Quality Auditor. In this critical role, you will lead and execute comprehensive quality audits across our network, including suppliers, third parties, internal business units, and manufacturing sites supporting marketed drug products. Your work will directly ensure that products, controls, policies, and processes rigorously adhere to the highest Pharmaceutical and Biotechnology industry quality standards, driving robust GMP Compliance.

Key Responsibilities

As a Quality Auditor, you will play a vital part in maintaining and enhancing our quality systems by:

• Independently conducting or participating as a lead/team member in various quality audits, including Supplier Audits, internal audits, and business unit assessments.
• Contributing significantly to the development and scheduling of the annual global audit plans.
• Organizing audit logistics, preparing agendas, and leading audit activities effectively.
• Executing Pre-Approval Mock Inspections to proactively prepare internal sites and Contract Manufacturing Organizations (CMOs) for official Regulatory Inspections, identifying and addressing quality system gaps.
• Providing expert cGMP guidance to support continuous improvement initiatives and ensure ongoing compliance with current regulations and industry best practices.
• Assisting in the analysis of key quality metrics to identify trends and opportunities for system enhancements.
• Offering crucial support during external third-party and regulatory agency inspections.
• Meticulously tracking audit responses and auditee CAPAs (Corrective and Preventive Actions) through to completion and final closeout.
• Continuously expanding your technical knowledge and auditing expertise across diverse areas such as API manufacturing, Analytical Laboratories, Sterile Drug Product production, Contract Packaging, and Mock PAIs.
• Supporting the collection and collation of vital auditing performance parameters to contribute to departmental reporting metrics.

What You’ll Bring

To succeed in this role, you should possess a strong foundation in pharmaceutical quality and auditing practices:

• Proven experience in conducting both internal and external audits within the Pharmaceutical or Biotechnology sectors.
• Solid technical knowledge of industry quality standards, including extensive understanding of GMP/cGMP regulations and guidelines.
• Experience across multiple relevant technical areas (e.g., API, Labs, Sterile Products, Packaging, Mock Inspections).
• Demonstrated ability to prepare clear, concise audit reports and communicate findings effectively to diverse stakeholders.
• The capability to work independently with a high degree of autonomy while also collaborating effectively as part of a team.

Why Join Us

We are committed to building a diverse and inclusive workplace where everyone feels valued. By joining our team, you will benefit from:

• A strong commitment to equal employment opportunity.
• A supportive work environment that values collaboration, respect, and professional growth.