Associate Director, GxP Quality, Compliance and Audit - Evinova

Associate Director, GxP Quality, Compliance and Audit - Evinova Durham, NC Job Details Full-time 1 day ago Qualifications Quality control corrective actions Regulatory inspections Stakeholder engagement Procedural guides 5 years Pharmaceutical regulatory compliance Engineering Supplier quality engineering practices Corrective and preventive actions (CAPA) Quality management GMP Implementing healthcare compliance training programs Supplier audits Team development Supplier audit compliance assessment ICH guidelines Bachelor's degree in biomedical science Bachelor's degree in engineering Clinical research compliance Bachelor's degree Continuous improvement Team management Decision making Quality improvement Mentoring Pharmacy Good Clinical Practice Training & development Root cause analysis Senior level Cross-functional collaboration Leadership Negotiation Stakeholder relationship building Cross-functional communication FDA regulations Training delivery SDLC Stakeholder management Full Job Description

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:

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

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 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 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 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

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 . #LI-Hybrid