Quality & Compliance Manager (hybrid)

Quality & Compliance Manager (hybrid) Req ID #:  204471 Location: 

Leiden, NL, 2333 CR For 75 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 Manager within Discovery of Charles River; you will be based at our state of the art drug discovery site in Leiden, the Netherlands.

As Quality & Compliance manager 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 quality & 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 Quality, Compliance, EHS and sustainability team.

•    advising on all Quality and Regulatory matters and providing local support.

•    organizing and carrying out internal audits.

•    instructing and providing training to local staff and new starters.

•    supporting the Discovery and Corporate quality reporting tools and accompanying CAPA program.

•    drafting, reviewing and/or approving and coordinating quality and regulatory procedures and hosting and maintaining those in a controlled environment.

•    responsible for regulatory processes and compliance with prevailing Dutch, EU and company laws and regulations.

•    identifying opportunities for improvement whilst making use of lessons learned.

•    potentially managing a small quality team within the wider Quality, Compliance and EHS&S team.

This role may require incidental travelling to other Charles River sites within Europe (mostly Belgium and United Kingdom)

The following are minimum requirements related to the Quality and Compliance Manager 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 a laboratory environment. Although most sites are non-GXP; an understanding of GLP/GMP/GCP is an advantage as Charles River is providing discovery and product development services at different sites meaning that projects may transition from non-GXP into GMP/GLP at other sites.

•    Fluent in English. Dutch is a pre (written and oral).

•    You have strong communication skills, are a good listener, with the ability to present information verbally and in written format.

•    You are pragmatic and at the same time adhering to the complex rules and able to advise, influence and engage site management and colleagues.

•    Excellent competency to manage change with the ability to overcome resistance.

•    Hands-on mentality to get the job done.

•    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 320 patents and 74 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 20,000 employees within 110 facilities in over 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. 

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 86% of the drugs approved by the FDA in 2021.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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