Senior Manager, QA Auditor, GCP Strategy

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

📋 Description

• Oversee audit planning based on risk 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 findings to identify trends and effectively communicate associated risks.

• Serve as the quality assurance representative on intricate cross-functional projects.

• Produce reports and metrics for Global Development leadership.

• Work collaboratively with stakeholders across global functions.

• Navigate complex situations while prioritizing multiple challenging activities.

⛳️ Requirements

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

• A minimum of 5 years in GCP audit strategy or direct audit experience.

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

• Experience in supporting or engaging in regulatory inspections.

• Strong abilities in project and stakeholder management.

• Exceptional written and verbal communication skills tailored for senior audiences.

🏝️ Benefits

• Annual bonuses or various incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company matching.

• Health and wellness programs.

• Access to fitness centers.

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