Posted on: Sep.13.2021
Req ID: 133056
Location: Leiden, NL, 2333 CR
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
Due to our continuing growth we have an exciting opportunity for a talented, highly motivated Quality & Compliance Officer at our state of the art drug discovery site in Leiden, the Netherlands.
As Quality & Compliance officer you are responsible for ensuring the efficient management of quality and compliance by implementing and maintaining an effective quality and regulatory management system.
You will be part of a small, international team which is responsible for compliance and executing on standards as well as the design and development of the areas of quality and regulatory compliance. All this is done in a team-oriented, result-driven, international research environment that provides an excellent career opportunity for an enthusiastic and motivated individual.
In your role you will be:
• an active participant of the Early Discovery Quality, Compliance and EHS team
• advising on all Quality matters, providing local support, organizing and carrying out internal audits instructing and providing training to local staff and new starters
• supporting the Discovery quality reporting tool and accompanying CAPA program for Leiden
• drafting, reviewing and/or approving and coordinating quality and regulatory procedures and hosting and maintaining those in a controlled environment
• identifying opportunities for improvement
• responsible for legal compliance with prevailing Dutch, EU and company laws and regulations
• fulfill a regulatory role such as the Leiden Test Substance Officer (Dutch Opioid Act); applying and keeping track of the permits, supervising use of controlled substances and regular reporting to the authorities
The following are minimum requirements related to the Quality & Compliance officer position:
• Bachelor's degree/HBO or equivalent level of degree is required
• A minimum of 5+ years of experience in Quality and (Dutch) Regulatory Management within laboratory environment
• Fluent in English, Dutch is a pre (written and oral)
• You are pragmatic and at the same time adhering to the complex rules and able to advise, influence and engage site management and colleagues
• You are a team player with cross-cultural skills as you will need to work with our team in Leiden, Beerse (Belgium) and various sites in the UK as well as Corporate (USA)
• You will be a focal point for our Leiden team and site management: good communication skills, able to train and guide staff on all levels on quality and compliance aspects
About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.