Senior Manager Operations Quality Assurance (QA)

R&D Partners; Tipperary; On-site; EUR 90,000 - 120,000; Full time

Job summary

R&D Partners in Ireland seeks a Senior Manager in Quality Assurance Operations to lead QA activities at a pharmaceutical manufacturing site. You will ensure products meet global regulatory standards and internal quality requirements while driving continuous improvement and cross-functional collaboration.

You will oversee training, document control, and batch certification, and mentor team members to achieve data accuracy and reliability, with a focus on efficient batch release and quality

Qualifications

• Experience upholding cGMP standards (FDA/EMA/ICH).
• Demonstrated ability to lead QA operations and drive continuous improvement.
• Strong track record in audits, inspections, and regulatory interactions.

Responsibilities

• Manage quality systems including training, document control, batch certification, and material release.
• Lead inspections, audits, and regulatory interactions with global regulators.
• Oversee QMS implementation and continual improvement initiatives across the site.
• Review and approve quality-related documents such as SOPs and validation reports.
• Monitor team performance to ensure data accuracy and reliability.
• Drive reduction of batch release cycle times and improve operational efficiency.

Skills

Leadership

Communication

Analytical

cGMP Knowledge

Audits & Inspections

Continuous Improvement

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.

For more information, please contact Billy O'Brien.