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Head of Quality Control
vor 4 Monaten
Job Description
Our quality assurance ensures that all materials and substances contained in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements. Through the close collaboration of our in-house production facilities and cooperation with external manufacturers and suppliers, we have established a tightly integrated global production network that is dedicated to reliably and punctually supplying customers and patients worldwide with products that meet high-quality standards.
To strengthen our team at our Friesoythe location, we are looking for you immediately and in full-time and unlimited capacity as Head of Quality Control.
Your responsibilities include, among others:
- Leading the quality control in accordance with AMWHV §12 and EU-GMP Guideline Volume 4 Chapter 2.8, and responsibility for quality control in accordance with 21CFR211.22: includes in particular
- Approval or rejection of starting materials, packaging materials, intermediates, bulk and finished products (EU), all components, drug containers, closures, in-process materials, packaging materials, labels, and drugs (US),
- Approval of specifications, sampling instructions, and test instructions, as well as ensuring compliance with these,
- Ensuring that all required tests have been carried out as part of material release and stability studies,
- Approval and monitoring of contract analysis labs,
- Control of the qualification, calibration, and maintenance of premises and equipment for testing,
- Ensuring the necessary validation of test methods or method transfer for the introduction of new products,
- Ensuring the required initial and ongoing training of testing personnel and
- Ensuring the retention of reserve samples.
- Leading the entire quality control consisting of analytical laboratory, microbiological laboratory, special lab, and lab service (approx. 60 employees). This includes:
- Selection and management of staff, including talent development and succession planning,
- Fulfilling entrepreneurial obligations for occupational safety, health, and environmental protection,
- Ensuring quality and compliance with relevant GMP regulations, such as AMWHV, EU GMP guidelines, FDA regulations, and pharmacopoeias,
- Ensuring sufficient personnel and equipment capacity for timely testing of starting materials, finished products, and stabilities, including short- and medium-term planning,
- Responsibility for the quality control budget.
- Sponsoring the implementation of quality and compliance excellence as well as continuous improvement and efficiency enhancement in the entire quality control and, if necessary, supporting initiatives at the site and company level.
Your profile:
- At least a Bachelor's degree in (Bio-)Chemistry, Biology, or a similar field of study,
- At least 5 years of professional experience in the pharmaceutical industry or another highly regulated industry in the biological or chemical sector working to quality standards (e.g., ISO, GMP, FDA/CFR, etc.),
- Minimum of 2 years experience as team leader in manufacturing or quality laboratories,
- Fluent in German, very good English skills,
- Strong leadership qualities, including the ability to drive behavioral changes and build talents,
- Strong analytical skills and creative thinking,
- Process optimization and improvement.
Our Benefits:
- Flexible working hours,
- Attractive compensation package (13 monthly salaries plus target bonus),
- Company pension scheme,
- Holiday pay (€1,200 annually),
- 30 days of annual leave,
- Employee discounts,
- Company bike / bicycle leasing,
- Contribution to Hansefit (fitness membership).
The stated goal of our Production & Delivery business area is to act as the most reliable manufacturer and supplier of biopharmaceuticals worldwide. Our production facilities, together with our external contractors, suppliers, and partners, form a tightly integrated global production network that is committed to reliably and punctually delivering high-quality products to customers and patients in every single case.
We are proud to welcome diverse talents and motivated individuals to our company. We promote diversity of ideas and a respectful, open climate in which employees exchange ideas and work together on new solutions. Welcome to a work environment where equal opportunities and diversity are embraced.
