Quality Systems and Compliance Specialist II

Job description

About ALK ALK is a global pharmaceutical company specialising in allergy immunotherapy. For over 100 years, we have helped prevent, diagnose and treat allergies, improving lives through science, integrity and patient commitment. Join ALK to support the quality and compliance of medicines that make a difference. The role You will maintain and improve the quality management system, ensuring compliance with regulations, procedures and quality standards. Working across the organisation, you will promote quality and continuous improvement. Your responsibilities will include: Maintaining and improving the quality management system. Coordinating document control, deviations, change control, CAPA and training records. Reviewing records and documentation for accuracy and compliance. Supporting audits and inspections, including preparation and follow-up. Monitoring quality metrics and reporting trends, risks and improvement opportunities. Guiding colleagues on quality processes and compliance. Contributing to investigations, risk assessments and improvement initiatives. Working with teams to complete quality actions effectively and on time. Your profile You have quality systems or compliance experience in a regulated environment, ideally in pharmaceuticals, biotechnology or life sciences. You will also bring: Knowledge of quality management systems and relevant Good Manufacturing Practice (GMP). Experience with document control, deviations, CAPA, change control or audits. A relevant degree or equivalent scientific, technical or quality-related experience. Strong organisation and attention to detail. Clear communication and effective teamwork. A proactive, collaborative approach and interest in improvement. Good spoken and written English; additional languages are an advantage. Become part of ALK At ALK, high standards, openness and a shared commitment to improving lives guide our work. Join an international team where collaboration, learning and quality matter. We value diversity, inclusion and wellbeing, and strive to create a supportive workplace where everyone can contribute. Application Submit your CV and application. We review applications on an ongoing basis, so apply as soon as possible using this link: All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents. To learn more about ALK, please visit our website at www.alk.net/us . If this position describes a fit for you, please submit through the link below. No agencies or recruiters please, we cannot support sponsorship for this position at this time or in the future.