Dr. Falk Pharma GmbH | Germany | 79xxx Freiburg | Permanent position | Full time / Home office | Published since: 04.09.2026 on stepstone.de
Head of Quality Assurance Issue Management / Qualified Person (m/f/d)
As a specialist in digestive and metabolic medicine and family businesses with global networking, we focus on the development and distribution of innovative medicines for various diseases of the liver, the bile ducts, the intestine and the esophagus to improve human life. We believe that we can only achieve medical progress together. So we are looking for:
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Your tasks • Your profile • What we offer
Your duties Team Quality Assurance Issue Management (5 employees) Ensuring high-quality and efficient processing of complaints, deviations and market action (e.g. recalls)
In Recall Management, you take over the overall coordination and are the key player for internal and external stakeholders
Perform all tasks and responsibilities as a qualified person in accordance with § 14 and § 15 AMG
Status assignment and certification of drug batches for national and international markets taking into account the applicable regulatory requirements (AMG, AMWHV, EU-GMP Guide)
Final examination and evaluation of batch documentation as well as change control applications, deviations, out-of-specification results and Product Quality Reviews (PQRs)
Contact person*in for pharmaceutical and quality-relevant questions during the product life cycle after market launch
Close cooperation with the Head of Quality, the Head of Quality Assurance as well as other experts and relevant interface functions
Your qualification Completed scientific studies
Qualification as a qualified person according to §§ 14,15 AMG
Multiannual experience in quality assurance in the GxP-regulated environment of the pharmaceutical industry and experience with national and international GMP regulations, as well as expert Professional experience in a comparable position is desirable Leadership experience and pronounced communication strength High level of responsibility and structured working Very good knowledge of German and English in word and writing
Your advantages New Work, Mobile Work and Flexible Working Hours Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Julia Odebrecht is available via e-mail at personal@drfalkpharma.de or under the telephone number 0761 1514 5513. We look forward to your application via our online portal.
Location
 | Dr. Falk Pharma GmbH | |
| 79108 Freiburg | ||
| Germany |
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