Job Description
Senior QC ManagerLocation: DublinCompetitive salary & benefits Join us as a Senior QC Manager at Alexion, AstraZeneca's Rare Disease division, where you will lead a team responsible for the quality control testing of Active Pharmaceutical Ingredients. This role offers an opportunity to oversee the day-to-day operations of the laboratory, ensuring compliance with regulatory requirements and company policies while driving continuous improvement initiatives. This is your chance to define a unique career in a leading biotech with the security and investment of a global pharma.Accountabilities:As a Senior QC Manager, you will lead and manage a team of QC analysts to ensure accurate and timely testing of analytical samples. You will develop and implement robust quality control procedures and protocols in accordance with regulatory standards. Your role will involve overseeing method transfer activities for new and existing analytical methods, collaborating cross-functionally with R&D, Manufacturing, and Regulatory Affairs to support product development and regulatory submissions. You will also manage laboratory resources, maintain a culture of safety and compliance within the laboratory, provide technical expertise, and ensure technical and Quality oversight of laboratory investigations.This role requires a minimum on site presences of three days a week.Essential Skills/Experience:B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.Proven leadership of laboratory staff and experience in a GMP laboratory.Proven ability to work in a matrixed organization.In-depth understanding of current regulatory requirements for QC, including QC testing, data integrity, supplier management.Knowledge of business and management principles involved in resource allocation.Experience of involvement in technical issue resolution, in a multidisciplinary environment.Strong organizational, conflict management and decision-making skills are required.Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.Desirable Skills/Experience:Supervisory/ management leadership experience.Experience of EQV, Empower and documentation systems would be an advantage.Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.Continuous learning mindset and willingness to adapt to evolving technologies and industry best practices.Strong project management skills with the ability to lead and coordinate cross-functional teams.Excellent communication and interpersonal skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.At Alexion, AstraZeneca's Rare Disease division, we are driven by our closeness to patients. Our brave, pioneering spirit makes us a beacon in the global Biopharmaceutical landscape. We offer an energizing culture where people build connections to explore new ideas and learn. Here, your career is not just a path, but a journey to making a difference where it truly counts. We invest in people who believe in the importance of our purpose and understand what it takes to deliver on it. Every day we change lives for the better – ours, people living with rare diseases, and the communities we serve.Ready to make an impact? Join us today! #J-18808-Ljbffr