Quality Assurance Manager / Deputy Technical Director

Grifols
Frankfurt
EUR 60.000 - 100.000
Jobbeschreibung

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

We are looking for a QA Manager / Deputy Technical Director to efficiently and effectively ensure all Quality activities in compliance with national and international GXP requirements and local laws as well as Grifols internal policies for all products distributed by Grifols Deutschland GmbH.

The position is key in managing all relevant QA systems at Grifols Deutschland GmbH in close cooperation with the Technical Director as well as the rest of the QA Team.

What your responsibilities will be

You will have the opportunity to :

  • Serve as the responsible person according to §52a AMG and the agreed internal responsibility matrix (as notified to the supervisory authority).
  • Be the back up to the Technical Director in all aspects of the QA-responsibilities.
  • Provide Quality Assurance review for storage and distribution of Biopharma and Diagnostics products in Germany.
  • Establish and ensure adherence to Grifols Quality-Systems and Policies as well as to European and local directives and legislation, including (but not limited to) maintenance of QA Systems SOPs, examining and supervising GxP compliance of storage and distribution of Grifols products, conducting self-inspections and internal audits as well as external audits of distributors, wholesalers and other third parties as assigned, etc.
  • Manage relevant QA systems, e.g. product technical complaints, deviations, documentation, change control, corrective actions, trainings and audits according to responsibility matrix and in coordination with the QA team.
  • Manage applications for OCABR as well as national release to the German OMCL (PEI).
  • Ensure establishment of Quality Management Business Review programs and annual business reports in cooperation with Technical Director and QA Team.
  • Support authority inspections.
  • Ensure QA relationship and agreements with contracted third parties.
  • Issue or review and approve reports for deviations, CAPA, change control and other relevant quality documents.
  • Ensure TD / QA onboarding for new hires.
  • Serve as the Key User for SAP QA Processes.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

  • You have a University Degree in Life Sciences (Biology, Pharmacy, Chemistry or similar). A Master’s Degree is also required.
  • You have at least 3 years of relevant experience in Quality Assurance, Quality Control and / or Quality Management.
  • You have knowledge of Document Management System and Project Management (desirable).
  • You possess good communication and organization skills.
  • You are a structured, self-motivated and results-oriented person, and team player, able to collaborate with cross functional teams to achieve the objectives.
  • You speak fluent German and English.

What we offer

It’s a brilliant opportunity for someone with the right talents.

Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.

Information about Grifols is available at. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.

We look forward to receiving your application.

Erhalte deine kostenlose, vertrauliche Lebenslaufüberprüfung.
Datei wählen oder lege sie per Drag & Drop ab
Avatar
Kostenloses Online-Coaching
Erhöhe deine Chance auf eine Einladung zum Interview!
Sei unter den Ersten, die neue Stellenangebote für Quality Assurance Manager / Deputy Technical Director in Frankfurt entdecken.