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:
You will be responsible for providing excellent leadership and strategic direction to the Pharmacovigilance Quality Assurance (PVQA) team which is responsible for Quality Assurance oversight of Pharmacovigilance activities to ensure compliance with (inter)national regulatory requirements for Good Pharmacovigilance Practice (GPVP). Moreover, you will collaborate closely with Quality Assurance (QA) peers and teams in other Astellas regions to provide comprehensive quality oversight and quality assurance for Astellas Pharmacovigilance activities.
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver
Key Activities for this role:
- Contributes to the design and strategic direction of the PVQA oversight and support to the Astellas organization in collaboration with the QA Leadership Team and stakeholders locally, regionally, and globally.
- Responsible for the development and execution of audits and as assigned, act as Primary Inspection Administrator for the facilitation and management of regulatory agency inspections and customer/license partner audits.
- Exceptional leadership capabilities and guidance to the functional groups for significant issue management (deviation/CAPA).
- Significant knowledge in driving new ideas and innovation to promote process improvement and risk mitigation to support Pharmacovigilance and overall Astellas’ Quality Systems. Provides guidance, expertise, and support to local and global PV project teams to ensure GPVP regulatory requirements are met.
- Extensive industry experience in managing audit and inspection information in Track wise and/or other electronic systems for reporting and metrics.
Essential Knowledge & Experience:
- Extensive industry experience in managing a Quality System within a GxP environment. Comprehensive knowledge of GxP and other regulations and understanding of global quality standards relating to product development, submission, and commercialization.
- Comprehensive knowledge of GPVP and other regulations for pharmaceuticals and biologics and understanding of global quality standards and regulatory authority inspection trends relating to product development and submission, as well as commercialization.
- Previous experience in establishing local and regional Quality policies and to influence the development and implementation of global Quality policies in support of the quality system.
- Demonstrate your ability to host and facilitate regulatory agency inspections and customer/license partner audits with successful outcomes.
- Significant experience in resolving complex and diverse problems with a significant impact within CRQA and across Astellas.
Preferred Knowledge & Experience:
- Quality assurance/auditing certification or credentials through recognized quality standards organization would be preferred.
- Bachelor’s degree or equivalent.
- This is a permanent full-time position.
- Position is based in the United Kingdom or Netherlands
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
What We Offer:
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
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.