Associate Director – Global Auditing

This is a fully remote position, open to applicants in Ireland, +4 more states.

📋 Description

• Execute GMP and GDP audits at manufacturing facilities, suppliers, contractors, business partners, and distribution networks.

• Evaluate adherence to regulatory standards, quality systems, and industry norms.

• Assist in due diligence, supplier qualification, and preparations for pre-approval inspections.

• Plan, perform, and document audits, ensuring timely and clear reporting of findings and recommendations.

• Collaborate with manufacturing, quality, supply chain, and compliance teams to mitigate risks and drive continuous improvement.

• Stay updated on changing regulatory requirements, industry developments, and best practices.

• Contribute to initiatives aimed at enhancing the effectiveness and efficiency of the audit program.

• Shape quality and compliance standards throughout a global manufacturing network.

• Cultivate relationships with both internal and external stakeholders while working autonomously across various locations and cultures.

• Travel frequently within Europe and other international regions, with an expected travel rate of up to 50%.

⛳️ Requirements

• Bachelor’s degree in Science, Engineering, Chemistry, Biology, or a related field.

• Extensive experience in the pharmaceutical sector or as a regulatory official.

• In-depth understanding of GMP requirements and quality systems that support pharmaceutical production.

• Background in Quality, Manufacturing, Compliance, Auditing, or similar regulated areas.

• Prior auditing experience in GMP-regulated settings.

• Experience with biologics, sterile, or other intricate pharmaceutical operations is a plus.

• Strong grasp of quality risk management, regulatory expectations, and compliance principles.

• Exceptional communication, influencing, negotiation, and report-writing abilities.

• Capability to work independently while effectively collaborating with global teams.

• Willingness to travel frequently within Europe and internationally.

• Comfortable with travel demands of up to 50%.

🏝️ Benefits

• Flexible working arrangements where feasible.

• Options for remote work.

• Commitment to equal opportunity and a diverse workplace.

• Support provided throughout the recruitment process.