About 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 support the Quality Assurance Document Records Program by setting up and managing a systematic process for assessing, reviewing, controlling, distributing, retaining, and archiving records from customers and stakeholders. You will manage the lifecycle of QA documents and records, including tracking system administration, filing, archiving, and retention. Ensuring regulatory compliance with global requirements such as cGMP, GLP, GCP, and electronic records and signatures will be a key responsibility. Additionally, you will lead continuous improvement projects for QA documentation processes that may impact multiple departments.
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:
- Administering the document control program within QA, establishing metrics for customer and quality optimization.
- Maintaining a central repository for all QA controlled documentation and coordinating processes for documents received from various sources.
- Creating procedures for documentation processes within QA to ensure compliance with global and regulatory standards.
- Facilitating the effective processing of all critical QA documents/records to ensure they are organized and retrievable.
- Collaborating with cross-functional departments and external entities to ensure proper tracking, review, and approval of quality documents.
Essential Knowledge & Experience:
- Proven experience in the pharmaceutical sector.
- Excellent communication, writing, and interpersonal skills, with the ability to collaborate across multiple departments and with external stakeholders.
- In-depth knowledge of GXP regulations and quality principles, with the ability to apply current interpretations and trends to quality documentation and record control.
- Skilled in creating SOPs for critical QA processes.
- Capable of independently managing projects, including overseeing internal and external resources, as well as remote and cross-regional teams.
Preferred Qualifications:
- Problem-solving skills to define business needs, identify possible solutions, and develop executable plans with available resources.
- Capability to work effectively in culturally diverse situations.
- Application of processes, methods, skills, knowledge, and experience to achieve specific project objectives within agreed parameters, timescales, and budgets.
- Ability to document processes in straightforward, easy-to-understand explanations and instructions within a QA subject.
Education/Qualifications:
- A bachelor's degree or equivalent experience is required.
- Fluency in English is essential for effective communication with global stakeholders.
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. 1 day per quarter in our Warsaw 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.
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