Job Summary
An information technology and services company has an open position for a Remote Quality Assurance Manager I in Boston.
Candidates will be responsible for the following:
- Supporting quality management implementation and maintenance
- Focusing on the management of authorized activities and the accuracy and quality of records
- Ensuring initial and continuous training programs are implemented and maintained
Qualifications for this position include:
- 0 - 3 Years of Experience
- Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance
- Strong leadership ability
- Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to pharmacovigilance
- Strong knowledge of pharmacovigilance AE reporting systems and regulations required
- Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems