Quality Assurance Manager (m/f/d)

AiCuris Anti-infective Cures AG

Wuppertal, Germany

The Powerhouse for Anti-infectives – Committed to making the difference.

AiCuris is a pharmaceutical company specializing in the discovery, research, and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies which has brought a drug with “blockbuster” potential to the market (Prevymis® 2017/18).

Ready to fight against infectious diseases? Join our team as a Quality Assurance Manager (m/f/d) in full time/reporting to the CEO.

At AiCuris, ensuring quality of our products and processes is of the highest importance. Bringing broad knowledge to the quality assurance function, you will work together with our project-teams during drug development up to approval regarding all manufacturing, non-clinical and clinical quality assurance aspects related to our development projects covering small molecules and biologics.

Responsibilities

Leads or contributes to the strategic direction for our risk-based quality assurance program;
Supports and continuously improves the QM system related to GxP;
Manages effective audit programs and performs audits;
Performs internal and external system audits;
Coordinates with external auditors to prepare, conduct and report outsourced audits;
Organizes and attends inspections by authorities or potential partners;
Oversees the process on non-compliances, controls corrective and preventive actions (CAPAs) and works together with all in-house functions and departments relating to quality issues;
Supports in vendor selection and qualification activities;
Provides expertise/consultancies on GxP-related items to the development teams;
Ensures compliance, maintains and further develops the company´s SOP system under a document management system, including review and approval of SOPs;
Plans, organizes and documents SOP and GxP trainings.

Skills and qualifications

Academic degree in natural science, pharmaceutics or medicine;
At least 5 years of experience with quality assurance management in the pharmaceutical industry regarding clinical‐and non‐clinical‐related activities (incl. CMC) during development (phases 1–3) until approval;
Very good knowledge of GxP regulations in Germany, Europe and the US;
Excellent communication, team working and leadership;
Good organizational and intercultural skills;
Flexible, scientific working style and willingness for continuous education;
Fluency in English.

What we can offer

Cooperation in multinational and interdisciplinary teams;
An exciting field of activity in a promising research and development company;
Flexible working hours and self-determined time management;
Flexible combination of on-site work and mobile working;
Regular and targeted further training and individual development opportunities;
Attractive remuneration and company pension scheme;
A wide range of offers in terms of health care and work-life balance.

How to apply

Interested in joining our team?

Then apply online using the Apply Now button below.

If you have any questions, please do not hesitate to contact us at +49 (0)202 317 63 - 0.

AiCuris Anti-infective Cures AG
Human Resources
Ariane Mlitzko Oliveira
Friedrich-Ebert-Str. 475/Build. 302
42117 Wuppertal, Germany
www.aicuris.com

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Don't forget to mention EuroPharmaJobs when applying.

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Quality Assurance Manager (m/f/d)