Location:
Europe: Luxemburg
North America: Boston, MA
Possibility to work from home
About Symfo
Symfo is an international SME based in Brussels, Belgium, and Boston, MA that specializes in creating robust and reliable electronic patient diary and data collection solutions for CROs, pharma, biotech and medical device companies conducting clinical studies or post-marketing surveys. Symfo is planning to open shortly a new office in Luxembourg. Visit us on www.symfo.com
Open Position
Symfo is currently recruiting a worldwide Regulatory Affairs and QA Manager. You will report directly to the QA director and will be in charge of QA and regulatory aspects of the Company.
Essential Duties and Responsibilities
- Maintain current Company SOPs.
- Improve and maintain a QA system.
- Manage and audit QA aspects with subcontractors.
- Prepare and attend Customer’s quality audits.
- Provide strategic regulatory advice to the CEO.
- Full-time position will include project management responsibilities.
Skills Required
- Demonstrates an excellent knowledge of ICH-GCP and global regulatory compliance.
- Demonstrates a good knowledge of clinical trials methodology.
- Demonstrates a working knowledge of Regulatory Guidelines (FDA and EMEA) and where to find these (21 CFR Part 11, Computer Validation, etc.).
- Demonstrates working knowledge of GAMP IV.
- Dynamic, flexible and trustable person who can work in a team and remotely.
- Initiative, Passion and the willingness to become immersed in work.
- Strong organizational, communication and time management skills.
- Familiar with computers and their applications.
- Speaks and writes fluently English.
Education / Experience Required
- Degree in Pharmacy or Life Sciences.
- Experience in a broad range of Regulatory Affairs projects.
- Five years experience with clinical trials.
- Experience with ISO norm and GAMP IV.
Travel
As required to achieve the goals for the assignment.
Offer
- An opportunity to make a real difference in a growing business.
- A challenging position with a high level of autonomy within a company where initiative, innovation and entrepreneurship are encouraged.
- A competitive salary package and benefits in line with your background and your achievements.
- Flexible schedule.
- Location flexible, home-working is possible.
Desired Profile Qualification:
Degree in Pharmacy or Life Sciences
Experience:
Five years experience with clinical trials.
Job Posted:
Tuesday, January 27, 2009
Recruitment Status:
N/A