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Quality Management System (QMS) Team Lead
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?
As a Quality Management System (QMS) Team Lead, you will be responsible for developing and maintaining our organization's Quality Management System (QMS). Your management of the system will ensure Aerogen’s products and services meet the relevant standards including EN ISO13485, FDA QSR and MDSAP. You will also lead System Engineers and Data Systems Analysts to support the organisation from a compliance and audit perspective.
What are the key responsibilities?
• Support with the further implementation of eQMS in collaboration with Programme Project Manager and SMEs across Aerogen.
• Continue to develop and maintain the current Quality Management System (QMS) in compliance with the ISO 13485 standard.
• Develop and maintain quality risk management policies, processes and procedures to support QMS implementation and improvement.
• Facilitate external certification assessment for ISO 13485 by organizing and overseeing the certification process.
• Identify any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal stakeholders
• Undertake quality risk assessments and maintain and update the Department’s Risk Register.
• Lead preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
• Coordinate the internal audit process and audit team to ensure that all audits are completed in a thorough and timely manner. Conduct quality audits and assessments to ensure compliance with QMS requirements and identify areas for improvement.
• Manage documentation related to the QMS, including policies, procedures, and records.
• Drive continuous improvement efforts and monitor and analyse quality performance metrics to identify trends and areas for improvement.
• Collaborate with cross-functional teams to implement quality improvement initiatives and resolve quality issues.
• Provide training to employees on QMS requirements and quality standards
• Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
• Promote the awareness of regulatory and customer requirements throughout the organization and ensure team members gather key data metrics for quality objectives and feedback at Management Review.
• Ensure team members complete quality training for new hires, and ongoing training from compliance reasons
• Lead and oversee a team ensuring effective coordination, communication, and collaboration.
• Ensure team is adequately resourced, manage recruitment of key talent (where necessary), with focus on retention of talent through engagement activities, action planning and meaningful work
• Mentor, coach and guide employees during their employment providing holistic performance feedback, develop IDPs, stretch & development opportunities to enable employees to progress career.
What education and experience are required?
• Bachelor’s degree in Engineering, Science, Quality Management, or a related field.
• Certification in Quality Management (e.g., ISO 13485 Lead Auditor) is preferred.
• At least 7 years’ experience working in a regulated device or pharmaceutical company.
What key skills will make you great at the role?
• Proven experience in maintaining a Quality Management System
• Strong understanding of ISO requirements and quality management principles.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.
• 3 years+ of people leadership experience in a growing company
• Strong emotional intelligence and ability to lead, coach and develop employees
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.
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?
As a Quality Management System (QMS) Team Lead, you will be responsible for developing and maintaining our organization's Quality Management System (QMS). Your management of the system will ensure Aerogen’s products and services meet the relevant standards including EN ISO13485, FDA QSR and MDSAP. You will also lead System Engineers and Data Systems Analysts to support the organisation from a compliance and audit perspective.
What are the key responsibilities?
• Support with the further implementation of eQMS in collaboration with Programme Project Manager and SMEs across Aerogen.
• Continue to develop and maintain the current Quality Management System (QMS) in compliance with the ISO 13485 standard.
• Develop and maintain quality risk management policies, processes and procedures to support QMS implementation and improvement.
• Facilitate external certification assessment for ISO 13485 by organizing and overseeing the certification process.
• Identify any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal stakeholders
• Undertake quality risk assessments and maintain and update the Department’s Risk Register.
• Lead preparation and coordination activities for external audits and liaise as required with SMEs to ensure audits are conducted in an efficient manner.
• Coordinate the internal audit process and audit team to ensure that all audits are completed in a thorough and timely manner. Conduct quality audits and assessments to ensure compliance with QMS requirements and identify areas for improvement.
• Manage documentation related to the QMS, including policies, procedures, and records.
• Drive continuous improvement efforts and monitor and analyse quality performance metrics to identify trends and areas for improvement.
• Collaborate with cross-functional teams to implement quality improvement initiatives and resolve quality issues.
• Provide training to employees on QMS requirements and quality standards
• Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
• Promote the awareness of regulatory and customer requirements throughout the organization and ensure team members gather key data metrics for quality objectives and feedback at Management Review.
• Ensure team members complete quality training for new hires, and ongoing training from compliance reasons
• Lead and oversee a team ensuring effective coordination, communication, and collaboration.
• Ensure team is adequately resourced, manage recruitment of key talent (where necessary), with focus on retention of talent through engagement activities, action planning and meaningful work
• Mentor, coach and guide employees during their employment providing holistic performance feedback, develop IDPs, stretch & development opportunities to enable employees to progress career.
What education and experience are required?
• Bachelor’s degree in Engineering, Science, Quality Management, or a related field.
• Certification in Quality Management (e.g., ISO 13485 Lead Auditor) is preferred.
• At least 7 years’ experience working in a regulated device or pharmaceutical company.
What key skills will make you great at the role?
• Proven experience in maintaining a Quality Management System
• Strong understanding of ISO requirements and quality management principles.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.
• 3 years+ of people leadership experience in a growing company
• Strong emotional intelligence and ability to lead, coach and develop employees
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.
Location
Ireland - Galway
Ireland - Galway
Department
QA/RA
QA/RA
Job Title
Quality Management System (QMS) Team Lead
Quality Management System (QMS) Team Lead
Salary
Experience
City
Galway
Galway
Country
Ireland
Ireland
