A subsidiary of a billion dollar medical device manufacturing company is hiring for a Quality Assurance Manager. As the Quality Assurance Manager, your main responsibilities will include developing and implementing a QMS, and building out the QA team. The role is a functional leadership role responsible for the control and implementation of the QA function within the organization. The position is fully on site based out of Fall River, Massachusetts.
Responsibilities
- Defining and specifying the goals and plans for quality assurance activity and compliance
- Review and release of batch orders
- Ensure internal and external audit compliance with timely and proper assessment and CAPA
- Implementation of a robust quality system
- Monitoring of KPIs and metrics of success to achieve goals and promote continuous improvement
- Review and approve all documentation to avoid close outs or delays in approval
- Assess and review training to ensure compliance and safety at the site
- Liaison between government agencies such as the FDA
Qualifications
- Bachelor's degree or equivalent experience in Chemistry, Pharmaceutical Sciences, Quality Management or related fields of study
- 7+ years' relevant work experience in GMP environment
- 2+ years of supervisory/team leadership experience
- Working knowledge of cGMP and regulatory guidelines
- Relevant and up to date knowledge about CFR part 11 regulations
- Relevant and up to date knowledge about ISO 13485
- Some experience with metered does inhalers (MDIs) or aerosols preferred
