Quality Consultant

TailorMinds; Leiden; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Pension entitlement

Collective insurance

Equal remuneration under NL collective

Illness coverage first year

Travel allowance

Job summary

TailorMinds in the Netherlands is seeking a Quality Consultant to support Life Sciences clients on GMP-regulated quality and compliance projects. You will investigate issues, identify root causes and implement practical, sustainable improvements across documentation, processes and systems.

You will collaborate with Quality Assurance, production, engineering and validation teams, handling deviations, CAPAs, OOS investigations and QMS enhancements, while communicating clearly with stakeholders and

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
• Experience in GMP-regulated environment.
• Knowledge of deviations, non-conformances, CAPAs, OOS investigations and RCA.

Responsibilities

• Manage and investigate non-conformances and deviations.
• Coordinate CAPA (Corrective and Preventive Action) processes.
• Investigate Out of Specification (OOS) results.
• Perform and facilitate Root Cause Analyses (RCA).
• Develop, implement and improve Quality Management Systems (QMS).
• Provide advice on quality and compliance within GMP environments.
• Identify opportunities for continuous improvement and implement practical solutions.
• Review and improve quality procedures, documentation and processes.
• Collaborate with Quality Assurance, production, engineering, validation and other stakeholders.
• Support organizations in maintaining a strong quality culture.

Skills

Analytical skills

Communication skills

English proficiency

Education

Bachelor’s or Master’s degree in Life Sciences/Engineering/Pharmaceutical Sciences/ Chemistry/ Biotechnology

Job description

Our client is an international consultancy supporting leading Life Sciences organisations with complex quality and compliance challenges. Consultants work on projects involving GMP, CAPAs, deviations, quality systems and continuous improvement, combining technical expertise with a hands-on consulting approach.

Are you passionate about quality and compliance within highly regulated environments? Do you enjoy solving complex quality issues and helping organizations continuously improve their processes?

We are looking for a Quality Consultant who combines strong analytical skills with a practical approach. In this role, you will support clients within GMP-regulated environments, providing advice and solutions for quality-related challenges and ensuring that processes, systems and documentation meet the required quality standards.

Your role as a Quality Consultant, you will work on a variety of quality and compliance projects within the pharmaceutical, biotechnology and Life Sciences industries. You will investigate quality issues, identify root causes and translate your findings into effective and sustainable solutions.

Depending on the project and client environment, your responsibilities may include:

• - Managing and investigating non-conformances and deviations
• - Supporting and coordinating CAPA (Corrective and Preventive Action) processes
• - Investigating Out of Specification (OOS) results
• - Performing and facilitating Root Cause Analyses (RCA)
• - Developing, implementing and improving Quality Management Systems (QMS)
• -Providing advice on quality and compliance issues within GMP environments
• -Identifying opportunities for continuous improvement and helping implement practical solutions
• - Reviewing and improving quality procedures, documentation and processes
• - Working closely with Quality Assurance, production, engineering, validation and other relevant stakeholders
• - Supporting organizations in maintaining a strong and sustainable quality culture

Requirements:

You enjoy getting to the heart of a quality issue rather than simply treating its symptoms. You are comfortable working in regulated environments and know how to balance compliance requirements with practical solutions.

Ideally, you have:

• - A Bachelor's or Master's degree in Life Sciences, Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology or a related field
• - Experience within a GMP-regulated environment
• - Knowledge of quality processes such as deviations, non-conformances, CAPAs, OOS investigations and Root Cause Analysis
• - Experience with or understanding of Quality Management Systems
• - Strong analytical and problem-solving skills
• - The ability to translate complex quality issues into clear and actionable solutions
• - Strong communication skills and the confidence to advise different stakeholders
• - A proactive, structured and hands-on approach
• - Professional proficiency in English; Dutch is an advantage

What do you get:

• - Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
• - Collective WGA / WIA insurance
• - NBBU collective labour agreement through equal remuneration
• - 100% payment in case of illness in the first year
• - Travel allowance per kilometer or through public transport