Evinova provides digital health software to streamline clinical development for sites, sponsors, and CROs. Its Unified Trial Solution enables remote patient monitoring, connected devices, eConsent,…
Evinova provides digital health software to streamline clinical development for sites, sponsors, and CROs. Its Unified Trial Solution enables remote patient monitoring, connected devices, eConsent,…
Associate Director, GxP Quality, Compliance and Audit - Evinova
HybridDurham, NC, US
Hybrid • Durham, NC, US
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WHY JOIN US?
Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector. By combining science-based expertise, evidence-led rigor, and deep human insight, we design digital solutions that enable healthcare to work better for everyone. Operating at the intersection of healthcare, technology, data, and analytics, we are helping unlock the full potential of digital health, transforming how clinical research is conducted, how care is delivered, and how patients experience healthcare. Our solutions are built to scale, driving efficiency, improving decision-making, and ultimately delivering better outcomes for patients worldwide.
At Evinova, we are driven by a shared purpose to transform health through data and digital innovation. Our teams collaborate across disciplines to solve complex challenges, continuously learning and evolving in a fast-paced, high-impact environment.
We also recognize the importance of flexibility and balance. Our ways of working support both individual needs and team collaboration. To foster connection and collaboration, employees are expected to work from the office three days per week, creating opportunities for in-person teamwork, innovation, and meaningful connection.
About The Opportunity
The GxP Quality, Compliance and Audit Associate Director will join a rapidly growing team at Evinova, offering a rare opportunity to shape and build the future of quality and compliance within a scaling health-tech business. This role will be instrumental in ensuring our clinical trial solutions meet global regulatory standards, including ICH, EMA, FDA, and other applicable guidelines.
You will drive innovative, efficient, and high-quality practices across the organization, while engaging with regulators and customers, contributing to industry forums, and playing a key role in audits and inspections. This is a highly visible opportunity to be at the forefront of digital health transformation.
What You'll Do
Essential Skills And Experience
Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Sciences, Engineering, or a related field
5+ years of experience in the pharmaceutical, biotech, or medical device industry
Strong knowledge of global GxP and GCP regulations, guidance, and standards
Desirable For The Role
Demonstrated ability to drive innovation within Quality and Compliance environments
Strong influencing, negotiation, and stakeholder management skills
Experience leading change and navigating complex, evolving environments
Excellent collaboration and relationship-building skills with internal and external stakeholders
Proven ability to develop and mentor talent, fostering long-term growth and capability building
Confident communicator with strong presentation and facilitation skills
SO, WHAT’S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Where can I find out more?
Explore what we’re building: www.evinova.com
Stay connected and see our impact in action: https://www.linkedin.com/company/evinova/
Are you interested in working at Evinova, apply today!
Evinova is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. Evinova is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
Date Posted
19-Mar-2026
Closing Date
02-Apr-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Lead the development, implementation, and continuous improvement of Evinova’s Quality Management System, ensuring alignment with GxP, GMP, FDA QMSR, MDR, ISO 13485, and other applicable standards
Provide GCP expertise across the software development lifecycle, ensuring compliance in design, testing, release, and operational activities
Guide teams on applying GxP principles to protect clinical data integrity, subject safety, and regulatory compliance
Plan and lead internal audits, including execution, reporting, and timely resolution of findings
Oversee supplier and third-party qualification and audit activities, ensuring readiness and accurate documentation
Own the Quality Issue Management process, including issue classification, root cause analysis, and CAPA development and effectiveness
Monitor quality trends across audits, issues, and CAPAs, identifying risks and driving continuous improvement
Deliver GxP training and education to internal teams and external stakeholders
Collaborate cross-functionally with Quality, Product, and Delivery teams to ensure alignment with GxP standards and business objectives
Support inspection readiness, including preparation, documentation, and regulatory inspection management
Oversee quality agreements, monitor performance metrics, and ensure service commitments are met
Stay current on evolving regulations and industry best practices, applying insights to strengthen quality and compliance processes
Lead and coach team members as required
Experience developing and maintaining Quality Management Systems in regulated environments, including SOPs and Work Instructions
Experience supporting and participating in Health Authority inspections (e.g., FDA, EMA), including preparation, hosting, and response coordination
Proven experience managing GxP compliance activities, including audits, issue management, root cause analysis, and CAPAs
Hands-on experience conducting GxP audits, including internal, external, and supplier audits
Experience applying risk-based approaches to GxP compliance and quality oversight
Knowledge of regulatory requirements for digital solutions supporting clinical trials
Experience with supplier qualification, audit execution, CAPA management, and metrics tracking/reporting
Ability to lead with integrity, inspire accountability, and promote a culture of doing the right thing
Pragmatic decision-maker, able to navigate complex scenarios, assess risk, and balance strategic and operational priorities
Resilient and proactive, with the ability to challenge the status quo and drive meaningful outcomes
