Lead, Quality Assurance – Italy 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: As the Lead, Quality Assurance (QA), Italy, you will be responsible for ensuring the compliant and efficient implementation and maintenance of the Affiliate Quality Management System.
Your work will support Astellas' commitment to providing patients with safe, effective, and consistently available healthcare products.
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.
Key Responsibilities: Ensure that all activities governed by Good Distribution Practice (GDP) Guidelines are performed and recorded according to the (global) Quality Management System, implementing improvements to address inefficiencies and non-conformances.
Lead communications with competent authorities responsible for pharmaceutical affairs, particularly regarding changes and recalls.
Conduct impact assessments of local and global changes in operations and regulatory requirements on product quality and availability, ensuring that an appropriate action plan is implemented to adjust the Quality Management System as needed.
Drive the successful implementation of a Quality Culture within the affiliate.
Essential Knowledge & Experience: Solid and relevant experience in a comparable role in the pharmaceutical industry.
Significant implementation experience and understanding of GDP, GMP, and Quality Management Systems.
Sound knowledge of the QA landscape and associated procedures within the country.
Excellent organizational, coordination, diplomatic, negotiation, presentation, and communications skills.
Proven ability to develop and maintain effective relationships with external bodies including national competent authorities.
Fluent in English and Italian languages.
Preferred Knowledge & Experience: Solid experience with Trackwise (Digital), Veeva and SAP systems.
Experience with coaching and mentoring (QA) people.
Significant experience in handling regulatory interfaces such as inspections and audits.
Education/Qualifications: Bachelor's degree or equivalent.
Additional Information: This is a permanent, full-time position.
This position is based in Milan, Italy.
This position follows our hybrid working model.
Role requires a blend of home and a minimum 2 days per week in our Italy office.
Flexibility may be required in line with business needs.
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 to 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.
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