Senior QA Consultant
Senior QA Consultant
National assignments, headquarters Hoofddorp - 32/38 hours
As a senior QA consultant within Progress-PME, you will fulfil a leading role in various quality-related assignment at our clients within the pharmaceutical- and biotechnology industry or healthcare sector. For example, you lead a significant quality improvement project, or you implement a quality management system, or you are the leader in an (FDA) inspection readiness program. Some of our Senior Consultants also act as an ad-interim quality manager or director. You support the client in the development, implementation, training and evaluation of their quality systems to ensure acceptance in the client’s organisation and operations. You can lead and perform, independently or in a team, audits, gap analyses and risk assessments.
Our job requirements:
- a university or Higher Professional Education (HBO) degree in biotechnology, chemical technology, biochemistry, pharmacy, or similar;
- 10-15 years’ relevant QA work experience in the (bio)pharmaceutical industry, within different companies preferably including (senior) QA management positions;
- experience with IGJ or FDA inspections, preferably in a leading role;
- broad project management experience;
- extensive knowledge of pharmaceutical production and familiarity with the cGMP requirements and other relevant regulations and guidelines, for example for quality management systems;
- experience with and understanding of ISO is a pré;
- experience in designing and implementation of quality improvement plans, policies, procedures and management reports;
- effective communication skills;
- proficient in Dutch and English.
- pro-active pragmatic attitude, flexible and customer-oriented;
- accustomed to balancing quality-related and operational activities;
- accustomed to working in a dynamic organisation;
- a thorough and systematic approach and capable of advising, influencing and motivating others;
- accustomed to communication at both senior and middle management levels and on operator level;
- capable of providing training courses for all layers of the organisation;
- accustomed to communication/consultation with government authorities and supporting health inspections.
- a healthy growing company with a collegial working atmosphere and focus on human capital;
- a varied job in challenging projects at renowned companies in the Life Sciences & Health;
- opportunities to develop as professional, both in function and by following courses, training and attending network-events;
- short communication lines, personal commitment, team spirit;
- engaging and learning environment;
- good work-life balance;
- more than market base salary and benefits;
- company car.
Meet some of our Senior QA consultants:
Klaas Geveke joined Progress-PME as project manager in June 2012. “I’ve been working in the pharmaceutical industry for almost twenty years and have been at this company for the past few years. I made a conscious choice for Progress-PME because I really enjoyed cooperating with their professionals when I worked for my two previous employers. What I noticed was that although these employees were seconded temporarily, for me they were not ‘external consultants’. They played an equal role and were just as involved with the people and the work as the organisation’s own employees. At that time I thought “I’d like to do consultancy work in that way too”. I’m happy I made that choice.
Chantal has been working at Progress-PME as a project manager and consultant since 1 September 2016. After graduating from Utrecht University as a pharmacist, Chantal Nobus started her career as a Production & Product Development Manager at Magistra. Here she was responsible for setting up a non-sterile production facility for liquid and semi-solid administration forms. In 1998, she started as a QA manager / Qualified Person in the pharmaceutical industry with CMO Herkel. With her expertise, she formed part of the new-build project team for the setup and validation of the premises in Zeewolde.