Associate Director, GxP Quality, Compliance and Audit - Evinova

AstraZeneca•Durham, NC

2d•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

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
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

Responsibilities

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