We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Regional Quality Assurance Manager France & Belgium
The role of the Quality Assurance Manager is the management and continuous improvement of PharmaLex Belgium and PharmaLex France local Quality System, in compliance with the corporate quality system for the full range of services provided by PharmaLex group: Regulatory, pharmacovigilance, epidemiology and risk management, development consulting and scientific affairs as well as quality management and compliance with a strong focus on Statistics/Pharmacometrics/Data Sciences, Computerized System Validation and Infrastructure & Technology.
- Setting up and monitoring of processes to ensure the compliance of the local Quality Management System with the ISO 9001 & GxP (mainly GMP, GCP and GAMP), regulatory/legal and clients’ requirements.
- Monitor quality metrics (KPI) and conduct quality management reviews
- Monitor compliance with PharmaLex training standards and documents
- Maintenance of the ISO/GxP QMS & preparation of the organization for ISO (re)certification
- Write and review procedural documents, coordinating regular reviews and updates
- Organize, perform and participate in internal, external and company vendor audits
- Lead client audits
- Management of corrective and preventive action documentation
- Management of nonconformities and complaints
- Organize and perform training on procedural documents, as needed
- Support the consultants for all types of QA related activities and, more specifically, the Statistics/Pharmacometrics/Data Science, software (SW) development and validation and IT infrastructure projects for process set up, quality control and quality oversight
- Quality alignment on filing of company documents and information for the Quality Assurance and also for Statistics/Pharmacometrics/Data Science, SW development and validation and IT infrastructure projects as applicable according to internal Quality management System , ISO, GxP and/or clients requirements
- Monitoring and centralization of project-specific quality documentation during the project and gathering the essential quality documents to send back to the customer at the end of the project
- Perform problem solving: identify sources of non-quality, develop assessment processes for quality of SW and Statistics/Pharmacometrics/Data science outcomes, provide recommendations for improvement
- Develop client leadership: ensure quality before delivery, develop supportive solutions in case of non-quality and quality by design mentality
- Collaborate with global QA and other QA-representatives within PharmaLex to further develop local and global QMS-system
- Administrative support related to quality management projects and activities
- Master’s degree in life science or related field with 5 years’ experience, or equivalent combination of education and experience
- Experience in defining and implementing quality systems and processes management as well as regulations
- Understanding / knowledge of pharmaceutical and medical device development from pre-clinical through commercialization
- Knowledge of ISO and GxP requirements
- Experience in supervisory management desired
- Outstanding organization, analytical, and complex problem-solving skills
- Excellent written, verbal and presentation communication skills
- Autonomous, concentrated and high-quality work
- Ability to work well in a collaborative team
- High level of ownership or core responsibilities
- Ability to adapt under regularly changing conditions
- Dependability according to expectations
- Knowledge of statistics/pharmacometrics/data science and computer system validation is a plus
- Knowledge in programming and software development is a plus
- English language fluency, verbal and written, French is a plus
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.