Job Description
Description Manager, Quality Assurance, Clinical QAAbout Astellas: At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. The Opportunity: As the Manager, Quality Assurance, Clinical QA, you will collaborate closely with Medical and Development (M&D) and other business units to support global and local drug development, registration, and marketing efforts across various Therapeutic Areas (TAs) and all stages of drug development. You will work alongside QA members and M&D teams to ensure alignment with company-wide standards and Quality Systems. Your role involves ensuring Quality oversight of M&D processes and clinical trials (Phase I-IV) to maintain compliance with international Good Clinical Practice (GCP) standards and other relevant regulations. Additionally, you will be responsible for managing, conducting, and participating in regional and global audits, managing external QA resources under the guidance of senior CQA staff, and providing technical expertise to identify and resolve quality issues.Hybrid Working: At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver. Responsibilities: Serve as the Global Quality Lead (GQL) on assigned M&D asset/study teams, developing Clinical Quality Assurance Oversight Strategies and conducting quality risk assessments. Ensure GCP compliance with the Astellas Quality Management System (QMS) and regulatory requirements, identifying and implementing corrective actions as needed. Conduct audits of clinical study sites, vendors, internal systems, and procedures, and manage quality issues related to major nonconformances or potential fraud. Support regulatory inspection preparation, defining strategies for inspection readiness and managing the rollout of inspection readiness programs across departments and regions. Track and analyze quality metrics, reporting to management and supporting the development of process improvements within Astellas R&D QA and M&D functional areas. Essential Knowledge & Experience: Significant experience in pharmaceutical, biotechnology, or related industry and relevant experience in Clinical QA. Project management/clinical monitoring experience, preferably in a matrixed, global setting, requiring facilitation, negotiation, problem-solving, and conflict-resolution skills. Understanding GCP requirements and practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle. Effective oral and written communication and presentation skills in English. Proficiency in Microsoft Office. Ability to travel at 10-25 % as required. Education: Bachelor's degree in sciences or equivalent. Additional information: This is a permanent full-time position.Position is based in the United Kingdom. The candidate should be located within proximity of 90 minutes of a major airport.This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our London office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.