cGMP Quality Compliance Project Leader
Location: SwitzerlandSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Zürich Switzerland.
Mid-large pharmaceutical organization with a broad drug portfolio of solid dosages.
Structured as a matrix organization but keeping simple and fast line reports.
ROLE DESCRIPTION
The cGMP Quality Compliance Project Leader is responsible for the implementation of an harmonized QMS across the organization.
It involves the creation of a Gap Assessment, development of a Remediation Plan, definition of Quality processes, implementation of a Risk Evaluation program, perform external party audits an act as the representative in front of the Health Authorities.
Within a matrix organization, this role involves the management of 6 direct reports and +50 indirect reports in several departments.
RESPONSIBILITIES
The cGMP Quality Compliance Project Leader will be responsible for:
- Implementation of a cGMP quality Reference across the organization
- Creation of a Gap Assessment
- Development of a Remediation Plan
- CAPA and Change Management
- Definition of Quality processes
- Implementation os a Risk evaluation program
- External audits
- Company representative in front of the authorities
- Team management
REQUIREMENTS
- Master degree in a scientific field (Biology, Chemistry, Pharmacy...)
- +7 years of relevant experience in a similar position
- Complete expert of GMP and ISO guidelines
- FDA knowledge is advantageous
- Previous experience as line manager
- Proficient German and English skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Patricia Oses Equiza.