General Information
Job Advert Title Quality and Continuous Improvement Lead Location Poland Function/Business Area Quality Employment Class PermanentDescription
Quality and Continuous Improvement LeadAbout Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
In this role, you will manage and oversee key business and operational processes and systems within the Functional Unit, including budget and contracts management, resource allocation, departmental information management, and tracking metrics and key performance indicators (KPIs). You will serve as the primary contact for cross-functional training requests, evaluating training needs, collaborating with LMS and Knowledge Management teams to assess training availability, and ensuring the Functional Unit remains inspection-ready at all times. Additionally, you will support LMS governance by overseeing the consistency and execution of LMS assignments internally and with vendors, represent Functional Unit training activities in various forums, and facilitate stakeholder reviews of quality documents and training curricula. Throughout, you will work independently while aligning with established processes, standards, and the Strategic Business Operations and Execution (SBOE) strategy.
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.
Key Activities for this role:
- Supporting vendor management strategy by overseeing outsourcing activities, ensuring compliance, analyzing costs, and driving operational efficiencies.
- Managing quality and continuous improvement initiatives, including audit support, CAPA oversight, and LMS assignment governance.
- Overseeing business and portfolio operations such as budget monitoring, meeting coordination, communication management, and maintenance of departmental sites.
- Supporting operating model and clinical systems by deploying new technologies, ensuring data quality, training teams, and managing eTMF and process compliance.
- Leading cross-functional training activities, evaluating needs, collaborating with LMS teams, ensuring inspection readiness, and representing training initiatives in various forums.
Essential Knowledge & Experience:
- Proven experience in the CRO or pharmaceutical industry, collaborating effectively with internal and external customers and business partners.
- Familiarity with Clinical Operations and Quantitative Science procedures, including roles such as Project Management, Study Management, Clinical Research Associate, Data Management, Statistics/Programming, and Medical Writing.
- Previous experience in training development, including researching and creating training materials and slides.
- Knowledge of Learning Management Systems (LMS).
- Strong communication and organizational skills, with the ability to multi-task and a high-level understanding of clinical study process flow from protocol creation to final clinical study report (CSR).
Preferred Qualification:
- Demonstrated ability to clearly communicate goals and expectations to internal teams and external stakeholders, ensuring alignment and fostering cross-functional collaboration.
- Proven experience in defining project goals, timelines, milestones, and managing interdependencies while holding stakeholders accountable for delivering on time and within budget.
- Strong negotiation skills with the ability to influence decisions positively by considering diverse viewpoints and identifying alternative solutions.
- Skilled in building consensus among stakeholders with differing perspectives, effectively resolving conflicts, and escalating issues when necessary.
- Sound decision-making based on systematic analysis of relevant information, with the ability to provide clear rationale and avoid assumptions or premature conclusions.
Education/Qualification:
- Bachelor’s Degree with relevant work experience in related fields or equivalent.
- Proficiency in business English is essential for effective cross-country collaboration.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Warsaw (Poland).
- This position follows our hybrid working model. The role requires a blend of home and approx. two days per week in our offices during the initial six months. After this period, on-site presence may reduce, depending on business needs and individual arrangements. 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.
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