Manager, Quality Assurance – EU Q&C Audit Defense Team

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

📋 Description

• Formulating and executing quality assurance strategies and processes to facilitate clinical trial operations.

• Performing quality evaluations and audits to guarantee adherence to regulatory standards and guidelines.

• Collaborating with project teams to detect and resolve quality concerns, and implementing corrective actions as necessary.

• Offering guidance and assistance to personnel regarding quality assurance policies, procedures, and best practices.

• Aiding in the creation and upkeep of quality management systems and documentation.

⛳️ Requirements

• Bachelor's degree in a pertinent field.

• At least 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO sectors.

• Familiarity with regulatory requirements and guidelines related to clinical trials (e.g., ICH-GCP, FDA regulations).

• Strong analytical and problem-solving abilities, with a talent for identifying and effectively addressing quality issues.

• Exceptional communication and interpersonal skills, with the capacity to collaborate efficiently with cross-functional teams and stakeholders.

• Openness to travel as necessary (approximately 35%).

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.