Working with an innovative Biotech to find their next Manager of Quality Assurance,GCP/GLP for their Boston location! You will be responsible for leading the Quality Assurance team and establishing their GLP quality compliance system, policies, and procedures for their GLP QA functions. If you are looking for a great opportunity to elevate your career keep reading!
Responsibilities:
- Manage GLP quality systems and perform audits and review and approve any deviations from SOPs.
- Develop and provide GLP training for staff for their Boston site.
- Communicate activities and feedback to core Quality management team to allow other team members to identify any issues or action items that need addressing.
- Communicate activities and feedback to core Quality management team to allow other team members to identify any issues or action items that need addressing.
- Recommends approval or disapproval of suppliers based on compliance assessment.
- Generate and maintain documentation in support of the Quality Management System
Preferred Experience:
- Bachelors, Masters or Ph.D. degree in pharmaceutical sciences/pharmacology, toxicology or life sciences.
- Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP, GLP related regulations
- A minimum of 6 years of related industry experience in Quality
- Strong project management skills
- Experience with participation in and hosting regulatory audits is a plus
