Associate Quality Assurance Manager
The Associate Quality Assurance Manager is responsible for the electronic documentation and learning management systems as well as ensuring compliance with US, Canadian, and EU regulations. Additionally, this position is responsible for administering quality programs including CAPAs, NCRs and SCARs. This position reports to the Head of Quality Assurance.
- Leads document management process execution and ongoing improvements across document content, scope, creation, approval, change orders/revision, and implementation
- Leads learning management activity including development and management of training content, creation of training validation methods, expansion of training matrices across all organizational functions, assignment of training, training metrics, and Quality Management System (QMS) training programs
- Identifies, validates, and owns ongoing maintenance and improvements of electronic application(s) for document and learning management
- Provides documentation advice at all levels of the company, including support to development of process and procedures that are compliant to international QMS requirements and product development/design controls
- Supports ongoing upgrades and validation of the electronic documentation and learning management systems, including qualification protocols, reports, and risk assessments.
- Provides reports on training metrics to senior management
Education and Experience Requirements:
- BS degree or postgraduate qualification in nursing, life sciences or medical sciences
- Five years experience with electronic documentation systems; Master Control experience being a definite plus
- A minimum of five years of experience in biopharmaceutical/device industry
- Experience in developing quality systems in a growing company
- Ability to work in a team environment
Skills and Abilities:
- You are passionate about your work and display a high level of emotional intelligence in your decision making
- You understand, appreciate and thrive in a growing organization and have the desire to learn new skills to contribute to company success
- You can manage various projects, solve problems, and deliver on commitments
- You can understand strategy, transition to execution, and effectively collaborate cross-functionally
- You have excellent communication and collaborative skills
- You strive for excellence and expect the same from your team and colleagues
scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.