Quality and Compliance Manager

Docuvera Software Corporation

2d•Remote

About The Position

At Docuvera, you’ll have the opportunity to contribute to work that matters, collaborate with talented people globally, and help shape the future of digital content in life sciences. We’re building technology that supports the highly regulated pharmaceutical/life sciences industry, where quality, trust, and compliance genuinely matter. It’s meaningful work, with real-world impact, supported by a globally distributed team that values autonomy, collaboration, and continuous improvement. Join us at a stage where there’s still plenty of opportunity to shape how things work, contribute ideas, and help mature processes in practical, visible ways. The part you'll play and why it matters You will take a key, hands-on role in maintaining and continuously improving our Quality Management System as our business scales across New Zealand, the USA, and Europe. Working as an independent function under the guidance of our executive team, you’ll take responsibility for day-to-day QMS operations, while actively contributing to our compliance with international standards and helping drive ongoing process improvements. As we expand our compliance footprint, we’re aligning with ISO 9001, ISO 20000, and maintaining our ISO 27001 certification and SOC 2 Type II report. We serve global clients with high expectations for data integrity, auditability, and regulatory alignment. You’ll help us meet both our regulatory and customer obligations, including requirements like EU GMP Annex 11 and 21 CFR Part 11. This role is perfect for someone looking to expand their quality and compliance skills in a dynamic, tech-driven environment. This role will keep our Quality Management System strong and audit-ready as we scale across New Zealand, the USA, and Europe. By owning day-to-day QMS operations as an independent function, you’ll strengthen real-world compliance, improve processes, and help maintain ISO 27001 and SOC 2 Type II while aligning to ISO 9001 and ISO 20000. Your work will reduce risk, support regulated requirements (including EU GMP Annex 11 and 21 CFR Part 11), and help teams move faster with confidence.

Requirements

Experience in quality management or compliance in a regulated environment (e.g. pharmaceutical, software-as-a-service, medical device, or similar).
Familiarity with regulatory frameworks, including ISO standards and GxP principles, and experience supporting compliance activities in an FDA/EMA or other regulated setting.
Experience with quality system processes (e.g., CAPA, change control, deviation management, document control, audit support).
Exposure to, or experience supporting, agile or lean delivery teams is an advantage.
Willingness to learn, adapt, and stay up to date with industry and regulatory changes.
A powerful sense of ownership and who proactively takes responsibility.
A willingness to provide direct feedback, suggest options to solve problems and to work with teams to improve and optimise their processes such that they are not an unnecessary burden on the company.
Proactive approach to identifying issues, recommending solutions, and assisting with process improvements.

Nice To Haves

College or university degree is desired
Relevant professional certifications in quality or compliance are advantageous.

Responsibilities

Be the SME for quality and compliance for Docuvera, acting as a point of contact for day-to-day quality and compliance matters, providing guidance to teams and escalating higher-level concerns as needed.
Maintain and improve the Quality Management System by updating policies, procedures, and records to ensure compliance with global standards and customer needs, with oversight from the CTO and other key stakeholders.
Coordinate external and internal audits by preparing documentation, facilitating audit activities, and supporting the closure of findings and CAPAs.
Work closely with our global Pharma customers, supporting them with their quality and compliance needs.
Monitor and track progress toward annual Quality Objectives, working with team leads to collect relevant information and implement improvement actions.
Participate in the evaluation and monitoring of external suppliers, including gathering and analyzing relevant quality data.
Support the risk management process by helping identify, track, and mitigate risks within the QMS framework.
Assist in the training and onboarding of staff on quality management processes, regulatory obligations, and best practices.
Prepare quality reports and actively contribute insights for management review and continuous QMS improvement.