European Quality Assurance (QA) Manager - Pharma (m/f/d)
- Erlangen, Germany
Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come and join our global team as European Quality Assurance (QA) Manager (m/f/d) to support our PETNET Manufacturing sites in France and UK maintaining their Pharmaceutical Quality Management System (QMS) in compliance with the EU cGMP regulation and relevant national legislation to an "inspection readiness" level.
Your tasks and responsibilities:
- In your role as European Quality Assurance (QA) Manager (m/f), you will take on a QA interface function between external contractors and our manufacturing sites to ensure support for QA projects at European level
- You will be responsible for conducting internal audits at the European manufacturing sites in France and Great Britain to ensure compliance with the current EU GMP regulations and conformity with the marketing authorisations. You will monitor the implementation of the resulting CAPA measures
- Ensure that the European Supplier Management Programme is maintained and carry out supplier audits as required
- They support the manufacturing plants in preparing for audits by external contractual partners and/or official inspections. You will also ensure that the resulting CAPA measures are implemented.
- You will work closely with the PETNET QPs and/or branch managers to ensure the adaptation and harmonisation of quality processes and microbiological procedures across all European PETNET branches
Your qualifications and experience:
- You have a university degree in chemistry, microbiology or pharmacy
- You have many years of professional experience in the field of "pharmaceutical quality system of a manufacturing plant" with
- During your career you have been able to build up a very profound knowledge and competence in the EU GMP regulations, especially with regard to radiopharmaceuticals
- In addition, you will have extensive experience in the manufacture of sterile medicinal products and the associated GMP requirements
Your attributes and skills:
- In order to be able to communicate effectively with the relevant internal and external stakeholders, you will have very good written and oral English skills. Ideally you also have a very good knowledge of German
- You enjoy business trips and are willing to travel internationally (approx. 30%)
- You have a talent for communication, act as an experienced coach and have excellent skills in guiding and supporting various stakeholders
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That's why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at https://www.siemens-healthineers.com/de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 - 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Katharina Tostmann.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.
Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
Organization: Siemens Healthineers
Company: Siemens Healthcare GmbH
Experience Level: Experienced Professional
Job Type: Full-time
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