About 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.
About this job:
In the role of Quality Assurance Affiliate Lead, you will play a pivotal role in managing the Affiliate Quality Assurance (QA) department. Your primary responsibility is to act as the primary contact for any quality issues within the Affiliate. You will contribute to the development and execution of QA Affiliate goals and objectives, aligning with the strategic plan.
Building and maintaining professional relationships with external contacts, ensuring compliance with local and company quality assurance requirements, and implementing a compliant Quality Management System are integral aspects of this role.
Hybrid working:
At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
In this role, you will:
- Lead the development and execution of our Global, Regional, and Local Affiliate QA objectives.
- Investigate and implement ways to enhance the compliance, efficiency, and effectiveness of the affiliate.
- Act as the key contact for competent authorities for QA and manage the department budget if applicable.
- Oversee QA Compliance Responsibilities, including establishing and maintaining the Quality Management system.
- Fulfil the role of GDP Responsible Person, ensuring compliance with regulations and making critical decisions in this capacity.
Essential Knowledge & Experience:
- Significant experience in implementing GDP, GMP, and Quality Management Systems.
- Proven track record of successful leadership in QA Projects and/or line management roles.
- Relevant experience in a comparable role in the pharmaceutical industry.
- Extensive Quality Assurance experience within the pharmaceutical industry.
- Ability to ensure compliance with Global, and Local Policies and SOPs
Preferred Knowledge & Experience:
- Having contributed to the development and implementation of QA objectives and plans in a similar role.
- Ability to perform training of Affiliate staff in QA processes, systems, and requirements.
Education:
- Bachelor's degree in a relevant field or equivalent.
Additional information:
- This is a permanent, full-time position.
- This role follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our Madrid 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.