QA Director

We are looking for a QA Director to join our Cambridge team in Massachusetts. The primary role of this position is to lead our QA team and optimize our QA processes.

Responsibilities:

• Manage and lead QA team (remote)
• Optimize our QA strategy that aligns with the company’s goals and objectives.
• Optimize our software testing process, including test planning, test case design, execution, and reporting.
• Maintain comprehensive documentation of testing processes, test plans, and test results for auditing and compliance purposes.
• Lead efforts associated with external audits against ISO regulations and standards

Ideal Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Biology, Pharmaceutical or a related field.
• 5+ years of experience in a QA management role for enterprise software
• 3+ years experience with QMS or Document management software and industry standards
• Extensive experience in quality assurance and software testing, particularly in a scientific software environment.
• In-depth knowledge of software development methodologies and QA best practices.
• Knowledge of relevant industry regulations and standards (e.g., FDA CFR Part 11, ISO9001 and ISO27001).

Who You Are:

• Have initiative to learn whatever is needed in order to complete your task
• Highly organized, and results-focused, with excellent written and verbal (presentation) skills
• Excellent at time management and Able to prioritize tasks and detail-oriented
• Self-motivated and people-oriented, with the ability to work collaboratively and productively in a global, multi-cultural environment
• Creative in inspiring customer loyalty, solving problems and contributing to best practices

Job Type: Full Time

Job Location: MA