Associate / Senior Associate / Principal Associate – Medicines Quality Organisation

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

📋 Description

• Assist in the creation, evaluation, and authorization of local quality documents, tools, and templates.

• Oversee deviations, change controls, and escalations, including conducting root cause analysis and CAPA.

• Offer quality oversight for various functional areas, which includes compliance monitoring, trend analysis, and action recommendations.

• Organize, prepare, and support audits and regulatory inspections, ensuring CAPA follow-up.

• Act as the main contact for quality-related inquiries and provide risk-based guidance to functional areas.

• Promote best practices, establish a network across quality groups, and contribute to various projects.

• Manage sensitive information, including patient data, audits, and inspections, with the highest level of confidentiality.

• Counsel the affiliate and/or region on quality requirements.

• Incorporate quality requirements into business processes and ensure alignment between global standards and local regulations.

⛳️ Requirements

• A degree in a natural science or a health-related field, or a qualification in a healthcare profession (e.g., pharmacist, nursing professional).

• Between 5 to 10 years of experience in quality, pharmacovigilance, or regulatory affairs.

• Hands-on experience in implementing quality systems within a regulated environment (GMP, GCP, GVP).

• Excellent analytical skills, attention to detail, and the ability to make risk-based decisions.

• Strong communication skills with the ability to effectively prioritize multiple tasks simultaneously.

• Proficiency in both German and English.

🏝️ Benefits

• Eligibility for a company bonus, which is partially based on both company and individual performance.

• Opportunity to participate in a pension plan.

• Vacation benefits.

• Access to healthcare benefits.

• Flexible benefits (where applicable).

• Life insurance and death benefits.

• Various time-off and leave-of-absence benefits.

• Well-being benefits, including an employee assistance program, fitness perks, and employee clubs and activities.

• Full-time employment.

• A 12-month fixed-term assignment for parental leave replacement.