QA Manager

6 days ago

Galway, Ireland TEAM HORIZON Full time

Team Horizon is seeking a QA Manager to lead the QA function at our clients manufacturing facility in Connaught. This position is responsible for ensuring that all products manufactured on site meet GMP requirements, regulatory expectations, and end-user standards, and will oversee team performance, manage compliance activities, and play a key role in preparing for and supporting audits and inspections. Why you should apply: This role offers the chance to lead a talented QA team within a highly regulated, dynamic, and collaborative environment, while playing a key role in ensuring that all products meet the highest standards of GMP, regulatory, and quality requirements. A great opportunity for someone who thrives in a leadership role, enjoys influencing quality strategy, and is passionate about driving continuous improvemenT What you will be doing: Ensure products manufactured meet requirements of end users, Regulatory Authorities, and company standards. Lead and manage the Quality Assurance team, providing guidance and support on quality and compliance matters. Act as a site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare site teams for successful outcomes. Manage CAPA (Corrective and Preventive Action) implementation, and follow-up activities. Collaborate cross-functionally to resolve quality issues, improve processes, and ensure continuous compliance with cGMP and other relevant regulations. Promote department goals by attracting, developing, and retaining capable QA staff. Contribute to talent management and professional development of QA personnel. Develop, review, and approve QA documentation as related to general QA activities. Provide oversight of batch record review, deviation investigations, change controls, and product release decisions. Support quality meetings and key quality metrics and trends. Communicate effectively with internal and external stakeholders, including the Quality and Compliance Group and regulatory bodies. Serve as a designee for the Quality Director as required What you need to apply: Bachelor's degree in science, Quality, Engineering, or related field ( Minimum of 8 years experience in the healthcare, pharmaceutical, or biopharmaceutical industry At least 3 years supervisory/people management experience Demonstrated experience with audits and/or inspections (FDA, HPRA, etc.) High level of expertise in day-to-day quality and compliance decision-making In-depth knowledge of GMP requirements and regulatory frameworks Strong attention to detail and commitment to compliance and quality standards Ability to facilitate quality decision-making while maintaining a strong patient focus and upholding company reputation Skills: Quality systems Audit Compliance Quality Assurance People Management Leadership Benefits: Pension Bonus Healthcare Career Progression

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