Senior Manager, QMS and Manufacturing Quality
About Aerogen:
Headquartered in the vibrant city of Galway, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and eight-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the role?
This role is accountable for the management and optimization of the Quality Management System (QMS) and Quality Manufacturing Engineering across three sites in Ireland, reporting directly to the Senior Director of QA/RA. The role will take ownership of enhancing and advancing our manufacturing processes, driving strategic continuous improvement initiatives, and developing and implementing robust quality control procedures. They will ensure full compliance with all applicable regulatory standards and industry best practices. The individual will foster a high-performance culture, providing mentorship and direction to the team while ensuring alignment with company culture, goals, and objectives.
What are the key responsibilities?
1. Quality Assurance and Control
• Support the manufacturing operation through the following activities:
• Own the Quality oversight of Master Validation Plans, Process Validations, and Verification of new manufacturing processes and sustaining activities.
• Apply expertise in statistical process controls and techniques to enhance manufacturing consistency and efficiency.
• Provide strategic direction and Quality inputs to the Risk management activities (Process FMECA) ensuring robust risk mitigation plans are in place.
• Lead the process/manufacturing data analysis, trending, assisting with yield reporting and collaborating with cross-functional teams to drive impactful improvements.
• Lead the root cause analysis of quality issues in manufacturing and manage quality-related NC's and CAPA's with a focus on long-term resolution.
• Oversee the Materials Review Board (MRB) process for assurance of economic compliance.
• Oversee the development and implement inspection plans, frequencies, and test methods for processing material/parts and finished goods.
• Manage process quality control system to ensure all manufactured products meet or exceed defined specifications prior to shipment.
• Take ownership of contamination control of the manufacturing environment ensuring compliance with industry standards and internal policies.
• Champion the adoption of cutting-edge technologies, automation, and systems across both manufacturing sites to enhance efficiency, quality, and competitiveness.
• Lead and oversee digitization of manufacturing processes, due diligence, development, validation, and implementation.
• Strategic Quality oversight for manufacturing transfers and NPD activities.
• Act as PRRC for Manufacturing ensuring all processes and outputs meet regulatory, quality, and compliance standards with the highest level of accountability.
2. Strategic Planning / Operational Efficiency
• Contribute, shape and implement the long-term strategic direction of both manufacturing sites, considering the need for upgrades or process reengineering based on company growth and external market demands.
• Embed Aerogen’s sustainability goals within quality engineering strategies, focusing on reducing energy consumption and waste and achieving environmental targets.
• Drive continuous improvement initiatives to enhance and optimize performance, reduce waste, improve quality, and lower costs.
• Implement digitized processes aligned with the Aerogen Digitization Strategy.
• Own and resolve quality engineering-related issues that impact production, quality, or safety.
3. Project Management
• Oversee and prioritize quality engineering and QMS implementation programme ensuring they align with business goals and operational needs for the 3 locations.
• Manage and optimize budgets for quality engineering and QMS projects for the 3 locations ensuring that projects are delivered on time, within scope, and on budget.
4. Compliance and Audits
• Ensure that products and processes adhere to relevant industry regulations, safety standards, and environmental guidelines in particular EU Medical Device Regulation, ISO 13485:2016: FDA QSR, MDSAP and other applicable regulatory requirements.
• Lead internal audit programs, assessing compliance and driving corrective actions to uphold quality standards.
• Proactively manage and mitigate risks associated with product quality, including identifying potential non-compliance or safety issues.
• Represent the business as a Management Representative, engaging with regulatory bodies and external auditors to ensure successful outcomes during certification and client audits.
5. Data Management / Analysis
• Leading the QMS team: ensure the collection, analysis, and reporting of quality data is accurate, up-to-date, and accessible for decision-making and demonstrates that the QMS is suitable, adequate, and effective.
• Maintain and govern the master data and management of the data inputs for the eQMS system.
• Monitor and analyze key performance indicators (KPIs) and use the data to drive continuous improvement efforts.
6. Vendor Software Management
• Management relationship with software vendors to ensure that the digital platforms under the scope of quality are properly maintained and upgraded.
• Evaluate and oversee the selection of third-party digital platform vendors or software solutions based on organizational needs.
• Manage software licenses, updates, and troubleshooting with the vendor as needed.
7. Security and Data Integrity
• Ensure data security within the quality digital platforms by adhering to cybersecurity best practices and regulatory requirements in line with the Aerogen IT strategy.
• Implement backup and disaster recovery procedures to protect critical quality data.
• Monitor for potential risks to data integrity and work to mitigate those risks.
8. Leadership and Team Management
• Lead, mentor, and oversee a team of over 20+ Quality Systems Engineers, Operations Quality engineers, and Document Control specialists/Change Analysts across 3 sites in Ireland ensuring effective leadership, communication, and collaboration.
• Oversee the recruitment of key talent, ensure teams are adequately resourced and budgeted, with focus on retention of talent through engagement activities and action plans.
• Foster a high-performance team culture providing feedback, coaching, and career development opportunities to empower team members.
• Champion collaboration and communication, ensuring effective coordination across sites and alignment with Aerogen’s strategic objectives.
What education and experience are required?
• A bachelor's degree in a relevant field (e.g. engineering, manufacturing, production management, or quality management).
• A master’s degree in a relevant discipline would be a distinct advantage for this role.
• Professional certifications: Qualifications in Lead Auditor / Internal Auditor; Six Sigma Certifications (Green Belt, Black Belt), Lean Management and Manufacturing Digitization Certifications are advantageous.
• 10 -12 years of experience in quality management and manufacturing quality engineering within the Medical Device or Pharmaceutical industry.
• Must be able to demonstrate a strong track record of Manufacturing Quality Management in an automated & lean manufacturing environment.
• 4-5 years’ experience of managing teams across multiple disciplines at a senior manager level.
• 3-4 years project management experience of implementing company-wide programmes.
• Strong technical leadership across multiple technologies.
• Excellent understanding of the EU Medical Device Regulation, ISO 13485:2016, MDSAP and FDA requirements.
• Experience with eQMS and MES systems implementation and operation.
What key skills will make you great at the role?
• Strong detail-oriented technical person with experience in product development, process engineering & scale-up as well as supporting supply chain infrastructure including supplier management and logistics.
• Strategic and analytical skillset to analyze data and identify opportunities for process improvement, and implement effective, compliant solutions.
• Extensive experience with data-driven methodologies for monitoring, controlling, and improving processes and products.
• Consistently demonstrates and promotes the highest levels of professional quality engineering, fostering a culture of continuous improvement.
• Self-starter who is willing to work through ambiguity and drive complex projects.
• Be able to respond to change and uncertainty by proposing alternative risk-assessed solutions for progression and implementation.
• Strategic thinker with outstanding influencing, persuasion, and negotiating skills.
• Strong leadership ability with demonstrated ability to lead, influence, mentor and manage a team of over 20 employees, across multiple sites, with a focus on performance reviews, fostering team development, and maintaining employee engagement.
• Demonstrates ability to work collaboratively and build relationships with key internal and external stakeholders including suppliers, customers, regulatory contacts to achieve results.
• Strong experience in strategic planning, prioritization, and budget management, ensuring alignment with organisational objectives.
• Ability to take initiative, work independently and as part of a cross-functional team.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:
• Excellent medical care.
• Bonus & Pension.
• ‘Aerogen Connect’ – our employee-led programme which supports our global teams to unite and have fun.
• We pledge 1% of profits and time to charities and organisations.
Check out our careers website to discover more about Life at Aerogen.
Aerogen is committed to promoting diversity, inclusion, and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
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