Medrio’s SaaS offering is a key component in the pipeline of getting lifesaving drugs to people who need them. We automate the clinical trial process and offer significant advantages over the competition, including 75% lower cost and quick, easy setup. Founded in 2005, Medrio is privately owned and currently experiencing geometric growth in terms of customers, revenue, and employees.
We are looking for an enthusiastic and experienced Quality Systems professional to join our team!
Responsibilities include, but are not limited to:
- Manage external client audits including:
- Working with external auditors to ensure audit plans correctly address Medrio offerings
- Scheduling external audits
- Providing audit support for ongoing audits
- Managing the observation response process, including associated CAPAs
- Promote and demonstrate FDA GxP and regulatory compliance.
- Execute vendor assessments, document supplier performance, and conduct audits.
- Participate in investigations and propose corrective actions.
- Recommend and implement improvements to the Quality System.
- Understand FDA and other regulatory requirements that pertain to work performed at Medrio.
- Travel Up to 25% travel required.
- Serve on a Computer Systems Validation team.
- Provide guidance or write Software Development Life Cycle deliverables.
Skills/Areas of Experience:
- Bachelor’s degree and 5-10 years of experience in regulated industry, or an equivalent combination of education and experience.
- 3 – 5 years of experience in managing external audits, preferably both remote and onsite audits.
- 3 - 5 years of experience in managing CAPAs.
- Demonstrated working knowledge of quality systems requirements per relevant regulations, including 21 CFR Part 11, Annex 11, ICH E6 (R2).
- Excellent communication and interpersonal skills.
- Ability to communicate effectively with Medrio clients.
- Ability to liaise successfully with project teams.
- Background in computer software validation
- Proficiency in MS Office and Google Docs required.
At Medrio, we look for smart, capable, and conscientious people to help us expand our product capabilities and better serve our customers. Our employees love working for us because they get to develop, market, and sell a product that advances human health, and they enjoy many perks, including
- An awesome, colorful HQ in downtown San Francisco with ping-pong, video games, and a kitchen full of healthy snacks.
- Great benefits: We offer medical, dental, vision, and life/LTD insurance, and we cover 100% of our employees’ health insurance premiums and 50% of dependent premiums.
- Wellness: Medrio values our staff’s well-being. To prove it, we promote an atmosphere of work/life balance, including flexible work schedules and locations.
- Weekly company-wide standup.
The Medrio team is made up of individuals with a wide array of skills, interests, and backgrounds but all have a passion for providing the best possible user experience for our customers. We value diversity, collaboration, ingenuity and creating a culture of excellence!
To see detailed information on the data we collect during the application process, and how Medrio complies with data privacy laws, visit our Careers page.