QA Manager - QP

The organisation

For our client, an highly innovative Contract Development & Manufacturing Organisation in the middle of Leiden's BioScience park, we are currently looking for a QA Manager with Qualified Person experience. The organisation evolves around supporting their clients with the progress they need to make developing their medicines.

The position

As QA manager you will manage the Quality Assurance department, oversee the daily activities and do the planning of both operative and improvement-related activities. You are responsible for people management activities with regard to the QA team, and act as direct point of contact with clients to manage quality topics such as quality agreements with clients, and lead preparatory activities towards client audits and regulatory inspections in close corporation with the QPs. Moreover, the role entails: Leading complex change control proposals and investigations in quality records; Identify the need for quality improvement/lean projects and enroll team members in implementation; Ensure that the identified improvement/lean projects are executed; Implementing GMP guidelines into quality procedures for continuous improvement of the QMS; Translate guidelines and regulations into daily practice; Advise and review documents for raw material selection, master batch records, analytical methods, including assay validations; Advise and participate in projects related to facility and equipment design, change proposals, URS preparation and C&Q documentation; Advise on design of process validations including: cleaning validation, sterilisation validation, media fills and decontamination processes of clean rooms; Develop and provide training on quality topics with QA department as well as within the organisation.

Candidate profile

• To excel in this position you bring along a Master’s degree in life sciences (Biotechnology or related) or a comparable level through experience in combination with a minimum of 8 years of relevant working experience.
• At least 3 years of people manager experience;
• Sound knowledge of European rules and regulations on GMP;
• Preferably knowledge of US rules and regulations on cGMP;
• Preferably experience with Lean management and 6 Sigma methodology;
• Good command of the English language, preferably also Dutch language (verbally and in writing);
• Excellent technical writing skills.

The offer

Besides the possibility to join an essential organisation and trusted partner for the Leiden BioScience park, this organisation offers a range of variety in job responsibilities. The benefits are:

• Competitive base salary, tailored to experience;
• End-year financial incentive;
• 30 holidays;
• Pension plan;
• Travel allowance;
• Personal/professional development possibilities. 
   

Interested?

You can apply for this position by using the link below.