Senior Quality Assurance Manager
Posted: 2 days ago
Job Description
Overview: An exciting opportunity for an experienced Quality Control leader to join a dynamic biopharmaceutical manufacturing site. This position is responsible for leading and developing the Environmental Monitoring (EM) and Quality Control support teams, ensuring compliance, sterility assurance, and operational excellence across all quality activities.Key Responsibilities:Lead and manage the Environmental Monitoring and QC Support teams, setting clear objectives and driving performance in alignment with company goals.Serve as the primary site contact for environmental and quality-related matters, ensuring compliance with GMP and regulatory requirements.Represent the site during regulatory inspections, maintaining strong alignment and accountability across the quality network.Ensure all EM and QC activities are executed in compliance with site SOPs, GMP, and corporate quality standards.Provide coaching, mentoring, and leadership to support team development and foster a strong culture of quality and safety.Deliver environmental compliance oversight to support aseptic manufacturing and cleanroom operations.Manage multiple competing priorities across site and functional responsibilities while maintaining clear communication and focus.Lead and support investigations and continuous improvement initiatives, driving efficiency and operational excellence within QC and EM processes.Support new product introduction (NPI) and qualification activities related to manufacturing and testing areas.Key Skills & Competencies:Excellent communication and presentation abilities, with confidence in conveying technical information across all levels.Proven leadership and people management skills, building collaboration and accountability within the team.Strong problem-solving and decision-making capabilities in a high-paced, regulated environment.Agile, proactive, and solutions-focused, with a commitment to continuous improvement.Sound understanding of data integrity, GMP, and regulatory compliance in sterile or aseptic environments.Experience managing environmental monitoring programs, aseptic technique training, and gowning qualification activities.Proficiency with Microsoft Office Suite and other business systems supporting reporting and compliance tracking.Qualifications:Bachelor’s degree in Biology, Chemistry, or a related scientific discipline (advanced degree preferred).Minimum 10 years’ experience in a GMP aseptic or sterile manufacturing environment, including hands-on leadership of Environmental Monitoring and Quality Control operations.Deep understanding of aseptic manufacturing standards, regulatory expectations, and sterility assurance principles.Demonstrated success in leading cross-functional teams, managing complex projects, and driving compliance excellence.Why This Role: This is a key leadership position within Quality Control, offering the opportunity to shape compliance strategy, enhance environmental monitoring performance, and play a pivotal role in ensuring the highest sterility and product quality standards within a world-class manufacturing environment.To hear more about this position or to discuss your suitability to please reach out to Nisha for a confidential chat on 01 632 5046 or email your CV to nisha.rutherford@recruiters.ie Your CV will not be sent to any third party without your consent.By applying here you agree to RECRUITERS storing your CV in our secure applicant tracking system (ATS; Bullhorn). As your consultants, we are dedicated to helping you find a new job in your field of expertise and, equally, to keeping your personal information secure at all times. Your CV will not be sent to any third party without your consent
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