Senior Manager, QA Auditor, GCP Strategy

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Oversee risk-based audit planning across various therapeutic areas and studies.

• Lead strategic audit initiatives utilizing risk indicators provided by study teams.

• Ensure that audits are in accordance with approved programs and adhere to scheduled timelines.

• Manage audit results to identify trends and communicate associated risks.

• Represent quality assurance in intricate cross-functional projects.

• Provide detailed reports and metrics to Global Development leadership.

• Collaborate with stakeholders across global functions effectively.

• Manage multiple complex tasks while successfully navigating through ambiguity.

• Willingness to travel 10–20% as necessary.

⛳️ Requirements

• Bachelor’s degree with over 8 years of relevant industry experience.

• More than 5 years of experience in GCP audit strategy or audits.

• Familiarity with FDA, EU, and ICH GCP regulations and guidelines.

• Experience in supporting or participating in regulatory inspections.

• Strong skills in project management and stakeholder engagement.

• Exceptional written and verbal communication abilities with senior audiences.

• Ability to travel 10–20% as necessary.

🏝️ Benefits

• Option for remote work.

• Annual bonuses or other incentive plans available.

• Equity awards provided.

• Pension or retirement benefits offered.

• 401(k) company match included.

• Health and wellness programs accessible.

• Access to fitness centers.

• Comprehensive insurance benefits (e.g., medical, dental, vision, life, and disability).

• Paid time off available.

• Family support benefits provided.

• Reasonable accommodations during the recruitment process for applicants with known disabilities or chronic illnesses.