European Quality Assurance (QA) Manager (m/f) Radiopharmaceutical Manufacturing

Job description

Job ID: 286764
Location: Erlangen
Organisation: Siemens Healthineers
Mode of Employment: Permanent

Now’s our time to inspire the future of healthcare together.

We at Siemens Healthineers are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind.

While we are investing in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also investing in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in the healthcare industry.

Join our team now at Siemens Healthineers as European Quality Assurance (QA) Manager (m/f) Radiopharmaceutical Manufacturing in Erlangen.

If you are ambitious and change makes you thrive, support the PETNET Manufacturing sites in France and UK maintaining their Pharmaceutical Quality Management System (QMS) in compliance with the EU GMP regulation and relevant national legislation to an “inspection readiness” level.

· You act as European document control approver. You review and revise QA documents on an European level
· You perform internal audits at the EU manufacturing sites in France and UK to ensure compliance with current EU GMP guidelines and Marketing Authorizations. You track and support the implementation of the resulting CAPA plans
· You maintain the European Supplier Management Program and perform supplier audits as required
· You support manufacturing sites during preparation for quality audits by external partners or regulatory inspections by the local competent authority and ensure timely implementation of the resulting CAPA plans
· You work closely with PETNET QPs and/or Facility Managers to ensure alignment and harmonization of QA and microbiological processes across existing European PETNET sites

This position may suit you best, if you have prior experience in pharmaceutical Quality Assurance.

· You have a university degree in chemistry, microbiology or pharmaceutics
· You have several years of work experience and at least 3 years of experience within Pharmaceutical Quality Systems of manufacturing sites including a solid know how and expertise in EU GMP guidelines, with specific knowledge related to radiopharmaceuticals
· You have a strong background in manufacture sterile medicinal products and related GMP requirements
· You have strong written and verbal communication skills – you are fluent in English and preferably also in German
· Occasional business trips are required (about 30%)
· You have the ability to supervise, coach and mentor others

If you want to join us in transforming the way healthcare is delivered, get in touch with us.

www.siemens.de/healthineers
if you wish to find out more about the specific business before applying.
+49 (9131) 7-35335
if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Ms. Petra Lehmann.
www.siemens.com/careers
if you would like to find out more about jobs & careers at Siemens.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.