QA Operations Team Manager

Ready to lead a high-performing QA team and drive quality excellence in a GMP-regulated pharmaceutical environment?

R&D Partners is seeking a QA Operations Team Manager to join a leading pharmaceutical company in Ireland. This role is pivotal in ensuring the Quality Management System (QMS) is inspection-ready and compliant with EU, UK, and US GMP regulatory requirements. The position offers an exciting opportunity to lead, manage, and train the QA Operations and Document Control team while driving continuous improvement across operational quality systems.

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

Responsibilities:

• Provide leadership, guidance, and direction to the QA Operations and Document Control team for smooth daily operations and continuous improvement.
• Act as the primary point of contact for operational quality issues.
• Develop, maintain, and manage the site's internal audit/self-inspection schedule, ensuring timely execution and follow-up on findings.
• Approve and support investigations of significant quality events and CAPAs.
• Ensure batch records are reviewed promptly to facilitate timely batch release.
• Collaborate with operational teams to remediate potential issues and minimize impact.
• Act as SME for QMS and documentation processes during regulatory and third-party audits.
• Manage risks, quality events, deviations, investigations, change controls, and CAPAs to meet timelines.
• Coordinate preparation activities for regulatory inspections and provide support during inspections.
• Lead hiring, onboarding, mentoring, coaching, and performance management for the QA team.
• Develop and deliver GxP compliance training to operational areas.
• Instill a quality culture within the organization through active mentoring and training.

Key Skills and Requirements:

• Education: Relevant science-based degree (e.g., Chemistry, Biology, Pharmacy).

Experience:

• Minimum 6 years in Compliance and Quality Assurance within a GxP environment.
• Leadership and management experience, preferably managing small teams.
• Hands-on experience defining and implementing Quality Management Systems.
• Experience in sterile/aseptic GMP manufacturing environments.
• Familiarity with EU Eudralex Volume 4, UK Orange Guide, US CFRs, and other relevant regulations.
• Competent authority regulatory body inspection and audit experience.

Skills:

• Strategic thinking and risk management.
• Proficient in Microsoft Office and eQMS systems.
• Excellent interpersonal, verbal, and written communication skills.
• Strong attention to detail and ability to prioritize workload effectively.
• Pragmatic approach to quality incidents.

For more information, please contact Frankie Cunningham.

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