Are you passionate about the power of technology to transform drug development in Life Sciences? Do you want to contribute to bringing highly innovative products and services to market, empowering people and organizations to achieve more? Are you detail oriented with a growth mindset, who can enforce a high quality and compliance bar for a fast-moving organization?
If so, we should talk.
Qualer is a San Diego technology growth company that has developed a groundbreaking SaaS platform for the Life Sciences and other regulated industries. As Quality Assurance Manager, you will leverage your existing Quality Assurance experience in either GxP and/or ISO environments, to take ownership of the Quality function at Qualer. In this role, you will provide oversight of our quality system, supervise change control operations, and manage CFR 21 Part 11 software validation projects—all to ensure we support the compliance of our customers as they run their mission critical operations on our platform. Along the way, you will play a strategic role in building out our larger Trust & Accreditation framework including SOC II, ISO 27001, and the NIST Cybersecurity Framework. If you are looking to fast-track your career in Quality, this is your opportunity.
About the Role
As Qualer’s Quality Assurance Manager you will:
- Take responsibility for the architecture and design of quality systems that ensure compliance with CFR 21 Part 11 regulations
- Manage ongoing GAMP 5 software validation during our multiple annual product releases
- Oversee software change control processes including risk assessment, issue tracking, and documentation
- Supervise the Software Design Lifecycle Development process
- Host and participate in regulatory body or 3rd party audits
- Coordinate training documentation and system tasks for new and existing employees, including management of the training matrix.
- Continuously identify and deliver more effective ways to drive performance
- Manage the approved vendor list and vendor audit schedule
- Design, build, and execute our Trust & Compliance roadmap including 3rd party accreditations (SOC II, ISO 27001)
- Bachelor’s Degree at minimum
- Experience in pharmaceutical, biotechnology or related industry
- Experience in Quality Systems management preferred
- Minimum one year of GXP experience
- Proven extensive technical writing experience, with the ability to provide work examples of such experience.
- Fun, hardworking atmosphere
- 100% company funded healthcare plans
- Dental insurance
- High growth environment, with opportunities for rapid career advancement
- 2 weeks of annual accrued paid vacation
If you’re interested in joining the team, please submit a cover letter and resume by clicking here. Thank you!