Associate Quality Assurance Manager

Job Description

The Associate Quality Assurance Manager is responsible for the electronic documentation and learning management systems.   Additionally, this position is responsible for administering quality programs including NCRs and CAPAs / SCARs as well as ensuring compliance with US, Canadian, and EU regulations. This position reports to the Vice President, Quality.

Key Responsibilities:

  • Leads document management process execution and ongoing improvements
  • 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, and training metrics
  • Identifies, validates, and owns ongoing maintenance and improvements of electronic application(s) for document and learning management including qualification and risk assessments
  • 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
  • Ensure the implementation and maintenance of Quality Systems including the compliance status of change controls, non-conformances, CAPAs and SCARs with suppliers
  • Provides quality performance metrics reports to senior management
  • Support Inspection Readiness activities for Quality Systems

Education and Experience Requirements:

  • BS degree or postgraduate qualification in nursing, life sciences or medical sciences, or equivalent work experience
  • Minimum of five years of experience in Quality Assurance in the biopharmaceutical/device industry, including a minimum of two years’ experience with electronic documentation systems; Master Control experience a plus
  • Experience in developing quality systems in a growing company

Skills and Abilities Requirements:

  • You excel at working both individually and in a team environment
  • 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.