Clinical Quality Compliance Manager
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Quality Compliance Manager based in United States.
This role offers the opportunity to shape and strengthen quality operations within a fast-growing healthcare and life sciences organization focused on improving clinical research.
The successful candidate will lead the execution and continuous improvement of quality management systems while ensuring compliance across clinical trials, software development, and regulated processes.
This position combines strategic quality leadership with hands-on operational ownership, supporting teams through scalable systems, risk management, and continuous improvement initiatives.
You will collaborate closely with clinical, technology, regulatory, and operational teams to embed quality by design throughout the organization.
The role is ideal for a quality professional who thrives in an innovative environment and is motivated by advancing patient-focused solutions.
Working remotely within the United States, you will contribute to building robust quality foundations that support the delivery of impactful healthcare technologies.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Quality Compliance Manager based in United States.
This role offers the opportunity to shape and strengthen quality operations within a fast-growing healthcare and life sciences organization focused on improving clinical research.
The successful candidate will lead the execution and continuous improvement of quality management systems while ensuring compliance across clinical trials, software development, and regulated processes.
This position combines strategic quality leadership with hands-on operational ownership, supporting teams through scalable systems, risk management, and continuous improvement initiatives.
You will collaborate closely with clinical, technology, regulatory, and operational teams to embed quality by design throughout the organization.
The role is ideal for a quality professional who thrives in an innovative environment and is motivated by advancing patient-focused solutions.
Working remotely within the United States, you will contribute to building robust quality foundations that support the delivery of impactful healthcare technologies.
Accountabilities:
- Implement and maintain a comprehensive Quality Management System aligned with regulatory expectations, including FDA requirements, ICH guidelines, 21 CFR Part 11, and ISO 9001 standards.
- Support the development of a strong quality culture by improving processes, workflows, and operational practices across the organization.
- Manage and optimize the electronic Quality Management System (eQMS), including document control, training management, risk management, CAPA, change control, supplier management, and audit processes.
- Monitor quality metrics, identify compliance risks, analyze trends, and implement proactive solutions to improve organizational performance.
- Lead CAPA and nonconformance activities, ensuring effective root-cause analysis and cross-functional remediation.
- Coordinate internal, external, and customer audits while maintaining continuous inspection readiness.
- Provide quality oversight throughout clinical trial activities, ensuring compliance with Good Clinical Practice (GCP) requirements during study planning, execution, and reporting.
- Partner with clinical operations and network teams to support protocol development, operational processes, and study oversight activities.
- Review software development deliverables and ensure technology releases meet quality and compliance requirements.
- Support software development lifecycle (SDLC) processes and ensure systems comply with applicable life sciences, FDA, and data integrity standards.
- Collaborate with engineering and product teams to integrate quality controls into development processes from early stages.
- Mentor and support quality team members while helping scale quality capabilities and operational effectiveness.
- Bachelor’s degree in a relevant discipline or equivalent professional experience.
- 8+ years of progressive experience in quality management within regulated industries.
- 2+ years of experience building, managing, or leading high-performing quality teams.
- Strong knowledge of regulatory frameworks including GCP, ISO 9001, 21 CFR Part 11, and related life sciences compliance requirements.
- Demonstrated experience managing clinical trial quality activities and supporting regulated clinical operations.
- Hands-on experience administering, configuring, or scaling an electronic Quality Management System (eQMS) in a fast-paced environment.
- Experience managing quality processes including audits, CAPA, risk management, document control, training systems, supplier management, and change controls.
- Familiarity with software quality practices, SDLC processes, and compliance requirements for regulated digital solutions.
- Strong project management, communication, and stakeholder collaboration skills, especially within distributed teams.
- Ability to work effectively across clinical, technical, regulatory, and operational functions.
- A proactive, adaptable mindset with a passion for continuous improvement and advancing healthcare innovation.
- Demonstrated values of collaboration, curiosity, humility, and commitment to positive change.
- Ability to travel occasionally as required.
- Competitive annual salary range of $134,985 – $163,247, depending on experience, qualifications, location, and other relevant factors.
- Equity opportunities at hire.
- Eligibility for a discretionary annual performance-based bonus.
- Comprehensive company benefits package.
- Medical, dental, and vision coverage.
- 401(k) retirement plan.
- Flexible and balanced remote work environment.
- Paid time off and company-supported holidays.
- Professional growth and development opportunities.
- Opportunity to contribute to meaningful advancements in clinical research and healthcare innovation.
The Clinical Quality Compliance Manager will be responsible for driving quality excellence across clinical operations, technology development, and organizational processes. This role requires a hands-on leader who can manage quality systems, ensure regulatory readiness, and promote a culture of compliance and continuous improvement.
Requirements:
The ideal candidate is an experienced quality professional with a strong background in regulated healthcare, life sciences, or digital health environments. They should combine technical regulatory knowledge with strong collaboration skills and the ability to build scalable quality systems in a growth-oriented organization.