- Manage the manufacturing Quality Assurance area, ensuring GMP compliance and on-time manufacturing and release
- Take responsibility for the release of materials, products, API, clinical test samples as a Qualified Person (in compliance with AMG Sec. 15 / EU GMP Guidelines)
- Lead the quality clinical trial material manufacturing functional area by example and coach and develop direct reports (appraisals and qualification measures)
- Part of the Manufacturing Leadership Team and CV Quality Leadership Team
- First contact for health authorities and inspections for Manufacturing GmbH
- Coordinate and ensure continuous quality optimization of processes between production and clinic, incoming goods, quality control, technology, logistics, shipping and quality management
- Collaborate cross-functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
- Ensure that the company's quality system is continuously adapted to international regulatory standards and is further developed
- Develop and maintain effective partnering relationships with customers and stakeholders
- Take responsibility for budget planning
- Ensure KPIs are implemented, monitored and reported to measure the effectiveness of the company ́s Quality System
- Ensure that deviations are adequately assessed and investigated and proper CAPAs are defined and implemented
- Perform self-inspections, customer, and regulatory audits
- Ensure the protection of life and health of employees and the company's property through active promotion of occupational safety
- Advanced degree in natural science (e.g. biology, microbiology, chemistry), ideally PhD or an equivalent qualification
- Experience in QA leadership in the pharmaceutical industry and several years of management and professional experience in clinical trial QA
- Fulfillment of the requirements for a qualification as a Qualified Person (according to AMG Sec. 14 and 15)
- Deep knowledge of and experience in pharmaceutical production and QA according to GMP standards and strong knowledge of GMP, GCP, GLP and related processes
- Sound knowledge of legal and regulatory requirements such as pharmaceutical law and the ICH-guidelines as well as basic knowledge of regulatory affairs
- Knowledge of regulatory environment, quality systems, HSE systems, continuous improvement management (SMS)
- Proven track record in change management and bringing teams to the next level
- Sound practical and theoretical knowledge of molecular biology and microbiology
- Executive presence and leadership skills with prior outstanding team management experience
- Fluency in German and English, both written and spoken
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Director / Head of Quality (f/m/d) Clinical Manufacturing & QP - Tübingen, Deutschland - CureVac
Beschreibung
CureVac Manufacturing GmbH, a wholly owned subsidiary of CureVac SE, is a biopharmaceutical company producing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies, prophylactic vaccines and molecular therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.
To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a
(Senior) Director / Quality Head (f/m/d) Clinical Manufacturing & QP
Your Responsibilities:
Your Qualifications:
We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.
Design your future with us – become part of the RNA people
We look forward to receiving your application via our CareerPortal.
CureVac Manufacturing GmbH
Human Resources
Till Zimmer
Friedrich-Miescher-Straße 15
72076 Tübingen
