General Information

Job Advert Title
Quality Assurance Manager and RP (Responsible Person)
Location
Hungary
Function/Business Area
Quality
Department
Quality Assurance
Employment Class
Permanent

Description

Quality Assurance Manager & RP (Responsible Person)


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:


The main role of the Quality Assurance Manager & RP (Responsible Person) is to lead and manage the Affiliate Quality Assurance (QA) department and act as the primary contact for any quality issues within the Affiliate. You will contribute in this role to the development and successful implementation and execution of the QA Affiliate goals and objectives as per the 5 year strategic plan.


As a Quality Assurance Manager & RP (Responsible Person) you will:


  • Liaise within the Affiliate and with global / regional quality assurance colleagues on matters relating to strategy, management and compliance that are impacting quality assurance
  • Develop and maintain professional relationships with relevant external contacts such as governmental bodies and pharmaceutical industry association, where appropriate and in line with Ethics and Compliance requirements and local legislation
  • To act as Responsible Person as defined in EU GDP Guideline 2013/C 343/01 (or equivalent)
  • To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorisation Holder
  • Accountable to ensure all Astellas products, personnel and third parties conform to local, European and company quality assurance requirements and these requirements are clearly understood within the Affiliate
  • Accountable to implement and maintain a Quality Management System, which is compliant with EU GDP Guidelines (or equivalent), local legislation and Astellas corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and marketing authorisation holder activities undertaken by or on behalf of the Affiliate.
  • Maintain independence with regards to QA decision making within the Affiliate

Essential Knowledge & Experience:


  • Minimum 3-5 years relevant experience in a comparable role in the pharmaceutical industry or in a regulated comparable industry
  • Proven ability to develop and maintain effective relationship with external bodies including national competent authorities
  • Quality Assurance experience within the pharmaceutical industry or in a regulated comparable industry is essential
  • Substantial experienced in handling regulatory interfaces such as inspections and audits
  • Fulfill requirements for Responsible Person from “39/2004 ESZCSM”

Preferred Knowledge/Experience/Qualifications:


  • Member of professional bodies and/or associations
  • Proactive involvement in external association activities and networking to enhance knowledge and expertise.
  • Maintaining and building currency of expertise and promotes best practice, knowledge sharing and compliance
  • Sound knowledge of the QA landscape and associated procedures within the country.
  • Significant experience of implementation and understanding of EU GDP, EU GMP and Quality Management Systems
  • Proven track record of having successfully led and delivered QA Projects. Significant proven track record of achievements in senior roles including cross cultural cooperation
  • Ability to coach and mentor less experienced personnel

Education/Qualifications:


  • University degree or diploma recognized as equivalent that allows to perform as an authorized/responsible person. (Pharmacy, Medicine, Chemistry, Medicinal Chemistry, Chemical Engineering, Pharmaceutical Engineering, Bioengineering, etc.).
  • Fluency in written and spoken English

Additional information:


  • Full time
  • Location: The position is based in Budapest

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.