About us

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and the market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.

Ardena is a rapidly growing international orientated organization with a dedicated team of over 500 professionals operating from 6 sites in Belgium, The Netherlands, Sweden, Latvia and Spain. Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.

We are a dynamic drug developer, offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come... together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with us by becoming our next colleague? Then we might have the right opportunity for you.

For the Ardena Business Unit based in Assen, The Netherlands, we are looking for a

Senior Manager / Director Compliance and Quality Assurance

KEY RESPONSIBILITIES
• You lead quality, improvement, and compliance awareness throughout the organization.
• You supervise the QA, validation and archiving department.
• You act as test facility/site management for GLP studies.
• You provide Quality Assurance support to bioanalytical assay development, validation and sample analysis.
• You ensure that all procedures and process flows related to bioanalysis are clear and up to date.
• You perform Risks Analysis on all lab and QA related processes.
• You coordinate all incidents, CAPAs, deviations and Risk Assessments.
• You plan and supervise validation activities for software, equipment and computerized systems.
• You host and supervise audits of clients and authorities.
• You manage the follow up of audits and responses to external auditors.
• You plan and initiate change controls of equipment and facility related items.

YOUR PROFILE
• You have a MSc or PhD, preferably in biomedical or other life sciences (e.g., pharmacy, (bio)chemistry or biology).
• You have in-depth experience with Quality Systems and Quality Management programs.
• You have a minimum of 5 years of QA experience (GxP) in a CRO, biotech, or pharma company.
• You have a sound knowledge of the GLP quality system and regulatory requirements related to bioanalysis is a pre.
• You are quality and result orientated and are continuously looking for improvement.
• You have inclusive leadership skills.
• You have a critical thinking mindset.
• You have active listening skills, you can analyse a quality issue, and explain the proposed solution in an accurate manner.
• You are solution driven, keeping timelines and budgets in mind.
• You are comfortable in stressful situations.
• You communicate clearly and effectively.
• You speak Dutch (preferably) and are fluent in English.

OUR OFFER
• A true learning environment where you will have the ability to grow your skills.
• A rapidly developing and growing international company with attractive services, product and customer portfolio.
• A dynamic working environment with friendly colleagues.
• Open straightforward but also caring culture.
• We are true to our values.
• An attractive remuneration package.
• Flexible working hours.
• 30 days holiday a year.

Do you have any questions? You can contact us by email: [email protected].

Ready to apply? Please click on the application button.

Only candidates eligible to work in the EU will be considered for this position. Unfortunately, given the high volume of applications we receive for our vacancies, professionals not entitled to work in the European Union will not be given a status update. Agency calls will not be appreciated
Assen Netherlands

Salary Criteria