EU Qualified Person (80%)

Stellenbeschreibung:

Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need.

Come and join our team to contribute to providing treatment options for patients with rare diseases that have a severe impact on the lives of affected children and adults. You can make a difference as:

EU Qualified Person (80%)

Who you are

You are an experienced and highly accountable EU Qualified Person (EUQP) with a strong background in pharmaceutical manufacturing and quality systems within a regulated EU environment. You bring a pragmatic, risk-based mindset and are comfortable taking independent batch release decisions in line with EU GMP, EU GDP and German pharmaceutical legislation.

You thrive in an in-house role where you can actively contribute beyond batch certification — partnering closely with Quality, Technical Development & Operations, Supply chain and external partners to ensure sustainable GMP and GDP compliance. You are confident interacting with Competent Authorities, able to challenge constructively when required, and comfortable operating with a high level of autonomy and personal responsibility.

You value on-site collaboration while appreciating a hybrid working model, and you are motivated by the opportunity to internalise critical regulatory know-how within a growing specialty pharmaceutical company. You are structured, detail-oriented, and resilient, with the credibility to operate at Director level in a matrix, international environment.

Scope of Work

Based on the EU GMP Guide Part One, Chapter 2.6, AMG §19, and AMWHV §16, the Qualified Person has the following tasks:

to approve or reject finished products for distribution in the EU and the EEC
to ensure that released finished product batches have been manufactured and tested in agreement with applicable GMP standards and with the marketing authorisation
to certify the conformity of each released batch in the batch release register (Freigaberegister)
to write and sign Certificates of Conformity (CoCs)
to assure that the required retention and reference samples are stored in agreement with AMWHV §18
to be the primary contact person for the Competent Authorities concerning tasks performed under the pharmaceutical manufacturing license (according to §13 AMG) of Santhera Pharmaceuticals (Deutschland) GmbH (SPDE)
to perform all Quality Management tasks not assigned to any other employee in writing (by an SOP or a job description)

The Qualified Person may rely in part on the certification performed by Santhera Pharmaceuticals (Switzerland) Ltd or by other Qualified Persons according to EU GMP Guide Annex 16. The ultimate responsibility for the tasks listed above remains with the Qualified Person releasing the batch for the EU.

Key Responsibilities

All responsibilities and competencies of the Qualified Person (“Sachkundige Person”) according to German Pharma Legislation
Final decision on finished drug product batch release independent from the executive management and other functions, provided that the necessary approvals by the Head Manufacturing and the Head Quality Control are available
Change of the release status of batches (e.g. extension or rejection)
Approval of all GMP relevant SOPs and similar documents valid for SPDE, by signing the SOP
Co-Signature of all Quality Assurance Agreements that SPDE closes with suppliers and service providers relevant for the quality or GMP compliance of finished drug products
Exchange of confidential information with the Competent Authorities, if required even without approval by the executive management
Creation and maintenance of the Site Master File (SMF) for SPDE

The job holder has the responsibility to train and comply with the Quality Documents indicated in the Santhera Training Matrix.

Required Qualifications & Experience

According to AMG §15,1 or AMG §15,2 or applicable transitory rules
Good knowledge of the pharmaceutical technology of the relevant dosage forms
Good knowledge of Analytical Chemistry and other applicable quality control procedures
Good knowledge of EU GMP regulations and guidelines
Good knowledge of the pharmaceutical legislation in Germany (particularly AMG and AMWHV)
Fluency in German and English
5+ years in the pharmaceutical industry
Attention to details with high sense of accountability
Excellent customer orientation and quality focus
Strong planning and organizing skills, able to manage multiple requests simultaneously
Excellent problem-solving skills
Solution oriented
Flexibility to adapt to changing priorities
Excellent interpersonal, networking and influencing skills
Ability to work independently as well as in large international project teams

If you are interested in a multicultural, challenging, and innovative working environment and your profile matches our requirements, we are looking forward to receiving your online application in English via LinkedIn or Email, at