Senior Manager Operations Quality Assurance (QA)

R&D Partners; Munster; On-site; EUR 110,000 - 140,000; Full time

Job summary

R&D Partners in Ireland is seeking a Senior Manager in Quality Assurance Operations to join a pharmaceutical manufacturing site. You will lead QA operations, oversee compliance with global regulatory standards, and drive continuous improvement initiatives while collaborating with cross‑functional teams.

Strong leadership and communication skills are essential, with deep knowledge of cGMP, FDA/EMA, and audit processes.

Qualifications

• Experience in QA operations within a pharmaceutical manufacturing context.
• Strong understanding of cGMP, FDA, EMA and international quality standards.
• Proven ability to lead audits, inspections and regulatory interactions.

Responsibilities

• Manage quality systems and document control, batch certification, and material release.
• Ensure compliance with global regulations and internal quality requirements.
• Lead inspections, audits and regulatory interactions.
• Oversee Quality Management Systems (QMS) and drive continuous improvement.
• Review and approve quality documents such as SOPs and validation reports.
• Mentor and develop team members to support professional growth.
• Represent the Quality function in leadership meetings and cross‑functional projects.
• Drive initiatives to reduce release cycle times and improve efficiency.

Skills

Leadership

Communication

Analytical

Regulatory knowledge

Problem solving

Team management

Job description

Ready to drive world‑class quality at a high‑performing pharma manufacturing site2? This Senior QA Operations role puts you at the heart of quality excellence.

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.

Please note that to be considered for this role you must have the right to work in this location.

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.

Key Skills and Requirements:

• 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.
• Ability to balance compliance with business needs in a fast‑paced environment.
• Experience in managing audits, inspections, and regulatory processes.
• Commitment to fostering a culture of quality and continuous improvement.