Senior QA Operations Leader, Quality & Compliance

R Dpartners; Tipperary; On-site; EUR 90,000 - 130,000; Full time

Job summary

R&D Partners is seeking a Senior Manager in Quality Assurance Operations to join a pharmaceutical manufacturing site in Ireland. This role focuses on ensuring that products meet global regulatory standards and internal quality requirements.

You will lead quality assurance operations, oversee compliance, and drive continuous improvement initiatives while collaborating with cross-functional teams. The right to work in Ireland is required.

Qualifications

• Strong leadership and team management abilities.
• Excellent communication and presentation skills.
• Analytical mindset with problem-solving capabilities.
• Knowledge of cGMP, FDA, EMA, and other international standards.
• Experience in managing audits, inspections, and regulatory processes.

Responsibilities

• Manage quality systems like training, document control, batch certification, and material release.
• Ensure compliance with global regulations and guidelines (e.g., FDA, EMA, ICH).
• Lead inspections, audits, and regulatory interactions.
• Oversee the implementation and improvement of Quality Management Systems (QMS).
• Review and approve quality-related documents such as SOPs and validation reports.
• Monitor and evaluate team performance to ensure data accuracy and reliability.
• Develop and execute departmental goals aligned with corporate strategies.
• Mentor and support team members for professional growth.
• Represent the Quality function in leadership meetings and cross-functional projects.
• Drive initiatives to reduce batch release cycle times and improve operational efficiency.

Skills

Leadership

Quality Assurance

cGMP

Regulatory Knowledge

Audit & Inspection

Data Integrity

Job description

R&D Partners is seeking a Senior Manager in Quality Assurance Operations to join a pharmaceutical manufacturing site in Ireland. This role focuses on ensuring that products meet global regulatory standards and internal quality requirements.

You will lead quality assurance operations, oversee compliance, and drive continuous improvement initiatives while collaborating with cross-functional teams. The right to work in Ireland is required.