Top 303 Clinical quality assurance manager Jobs in Remote

Quality Assurance Manager - GCP
Cognitive Research Corporation —Remote
- Remote
- Nursing
- Bachelor of Science
- Writing skills
Quick Apply
Manager, Quality Assurance
Clario —Remote
- Full-time
- Remote
- 7 years
- HIPAA
- Business development
- Health insurance
- Dental insurance
Clinical Sample Manager
SAB —Remote
- $130,000 - $150,000 a year
- Full-time
- Microsoft Excel
- Bachelor's degree
- Travel
Quick Apply
Manager-Quality Assurance Auditor- GCP
Regeneron —Remote
- $114,800 - $187,400 a year
- Project management
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Associate Director, Clinical Quality Assurance
Vera Therapeutics, Inc. —Remote
- $140,000 - $210,000 a year
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
- Paid holidays
- Health insurance
Executive Director, Global Pharmacovigilance Operations, Quality & Compliance
Ultragenyx Pharmaceutical —Novato, CA
- $301,100 - $371,900 a year
- Full-time
- Remote
- 11+ years
- Children
- Travel
- Gym membership
Physical Security Design Manager
EXANTE360 INC —Newport Beach, CA
- $105,000 - $130,000 a year
- Full-time
- Remote
- Construction site
- Microsoft Office
- Senior level
- Disability insurance
- Health insurance
Quick Apply
3d
Clinical Quality Assurance Manager
Centria Autism —Farmington Hills, MI
- $80,000 - $85,000 a year
- Monday to Friday
- Remote
- Google Workspace
- Applied behavior analysis
- Management
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Senior Manager Quality Audit Operations (Clinical Chart Validation)
Cotiviti —Remote
- $120,000 - $160,000 a year
- Full-time
- Computer Science
- HIPAA
- 3 years
- Paid holidays
- Disability insurance
Senior Manager Quality Compliance (Rare Disease)
Amgen —Remote
- $132,037.30 - $178,638.70 a year
- Remote
- 7 years
- Bachelor of Science
- Writing skills
- Disability insurance
- Health insurance
vIOP Clinical Quality Manager
Lyra Health —Remote
- $136,800 - $152,000 a year
- Full-time
- Remote
- Master of Social Work
- Psychiatry
- Urgent Care
- Paid parental leave
- Health savings account
7d
Manager, Clinical Review and Quality Assurance
SmithRx —Remote
- $163,200 - $192,000 a year
- Remote
- Analysis skills
- Mentoring
- Training & development
- Commuter assistance
- Paid parental leave
Quick Apply
6d
Lead Clinical Research Associate/Trial Manager
Ardence Consulting LLC —Remote
- $70 - $90 an hour
- Temporary
- Management
- Patient monitoring
- HIPAA
Quick Apply
13d
Clinical Operations Coordinator
Trusted Ally Home Care —Remote
- $85,000 - $95,000 a year
- Full-time
- Remote
- RN License
- Mid-level
- Home Health
- Health insurance
- Dental insurance
Quick Apply
7d
Senior Manager, Clinical Operations
Precision Medicine Group —Gladstone, NJ
- $147,300 - $220,900 a year
- Online Application
- Remote
- 5 years
- Bachelor's degree
- Organizational skills
5d
Senior Clinical Program Manager
LivaNova —Remote
- $160,000 - $190,000 a year
- Full-time
- Microsoft Outlook
- Writing skills
- English
- Employee stock purchase plan
- Health insurance
3d
Sr. Manager/Associate Director, Clinical Monitoring Oversight
Aura Biosciences —Boston, MA
- $150,000 - $215,000 a year
- Weekends as needed
- Remote
- Nursing
- Bachelor's degree
- Travel
- Employee stock purchase plan
- Disability insurance
Quick Apply
Senior Clinical Trial Manager (CTM)
Praxis Precision Medicines, Inc. —Remote
- $168,000 - $188,000 a year
- Email
- Remote
- 5 years
- Bachelor's degree
- Senior level
- AD&D insurance
- Employee stock purchase plan
Quick Apply
Clinical Consulting Manager
Netsmart Technologies —Remote
- Extended hours
- Remote
- Background check
- Master of Social Work
- Nursing
- Opportunities for advancement
5d
Manager, Complex Clinical Review
Machinify —Remote
- $115,000 - $130,000 a year
- Remote
- Nursing
- Microsoft Excel
- RN License
- Health insurance
- Dental insurance
5d

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clinical quality assurance manager jobs near remote

Quality Assurance Manager - GCP

Cognitive Research Corporation -
Remote

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Job Details

Qualifications

Operational analysis
Nursing
Performance improvement leadership
Risk management compliance audits
Confidential information handling
Quality records maintenance
Defect resolution root cause analysis
Data analysis reporting
Operations management
Document control experience within pharmaceutical industry
Procedural guides
Clinical trial risk management
Clinical research audit management
Bachelor of Science
Preventive action implementation
Master of Public Health
Writing skills
Quality control preventive actions
Corrective and preventive actions (CAPA)
Metrics Reporting
Quality reports
Vendor compliance audits
Quality control data reporting
Supplier audits
Clinical audit and monitoring
ICH guidelines
Bachelor's degree
Decision making
Industry trends
Master of Science

Full Job Description

The Quality Assurance (QA) Manager plays a critical role in overseeing and executing Clinical Quality Assurance activities that uphold and enhance the organization’s Quality Management System (QMS). Reporting to Quality Assurance Leadership, this position ensures compliance with ICH GCP, applicable global regulations, and internal quality standards, while fostering a culture of continuous improvement.

The QA Manager leads key quality functions, including audits, quality event management, vendor qualification, training, and risk-based quality planning. This role partners cross-functionally with clinical operations, vendors, sponsors, and leadership to maintain operational excellence and ensure that clinical research activities meet both regulatory and sponsor expectations.

Essential Duties and Responsibilities:

Quality Assurance Operations

Manage and monitor clinical QA activities, ensuring compliance with QMS, ICH GCP, and regulatory requirements.
Execute day-to-day QA operations to support the QMS while meeting business goals and sponsor requirements.
Foster a quality-focused culture, promoting awareness and driving continuous improvement initiatives across clinical programs.
Maintain current knowledge of industry best practices, quality trends and evolving regulations, integrating insights into QA decision-making.

Quality Management System (QMS) & Documentation

Develop, author, review, and maintain QMS documentation, including SOPs, Work Instructions, Templates, and Forms.
Support Quality Management Review (QMR) activities, including data analysis, reporting, and tracking action items to completion.

Quality Events & CAPA Management

Oversee the management of Quality Events and CAPAs, ensuring timely investigation, root cause analysis, effectiveness checks, and closure.
Review and assess clinical site and vendor Quality Events, ensuring appropriate resolution and compliant documentation.
Evaluate CAPA plans for adequacy, regulatory alignment, and operational feasibility.

Audits & Inspection Readiness

Lead or support the planning, conduct, and documentation of internal, vendor, and clinical site audits, including detailed reporting and CAPA tracking.
Lead or support sponsor audits and regulatory inspection readiness, including preparation, hosting, and follow-up activities.
Author and review audit responses, ensuring timely, accurate, and effective resolution of findings.

Vendor Qualification & Oversight

Lead or support vendor qualification and requalification, including risk-based assessments, audits, and ongoing compliance monitoring.

Risk-Based Quality Management

Apply a risk-based approach to support the planning, prioritization, and execution of quality initiatives.
Identify, assess, and mitigate quality and compliance risks across clinical studies and operational areas.

Quality Metrics & Continuous Improvement

Analyze quality data and metrics, including audit trends, Quality Events, and CAPA outcomes, to identify patterns and drive process improvements.
Provide regular reports to senior leadership on quality trends, risks, and mitigation strategies.

Cross-Functional Collaboration

Collaborate with clinical operations, medical, regulatory, and vendor teams to ensure alignment on quality expectations and risk management.
Provide QA consultation for controlled document development, process optimization, and clinical trial execution.

Business Development & Sponsor Support

Assist with sponsor RFIs, due diligence questionnaires, and quality agreements, ensuring timely and accurate responses.
Serve as a QA representative in sponsor meetings, fostering strong sponsor relationships and transparent quality communications
Perform other duties as assigned by management.

Qualifications:

Education & Experience

BS/BA/MS in Life Sciences, Pharmacy, Nursing, or a related field, or equivalent combination of education and experience; advanced degree (e.g., MS, MPH) preferred.
5-10 years of GCP Quality Assurance experience, preferably in a CRO environment.

Knowledge & Skills

Deep knowledge of ICH GCP, FDA and other global regulatory guidelines.
Experience in authoring, reviewing, and managing QMS documents and quality records.
Excellent written, verbal, and presentation skills, with the ability to communicate complex concepts clearly.
Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
Strong organizational, time management, and prioritization skills; able to manage multiple projects in a fast-paced, matrixed environment.
Analytical and risk-based thinking, with the ability to interpret quality metrics and drive continuous improvement.
Effective in influencing, negotiating, and implementing effective quality solutions.
Meticulous attention to detail with auditing and investigative skills.
Proficient in Microsoft Office, QMS systems, and electronic Trial Master File (eTMF) platforms.
Ability to handle sensitive and confidential information with discretion and integrity.
Ability to travel <10%.

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Refine Your Search

clinical quality assurance manager jobs in remote

Quality Assurance Manager - GCP

Manager, Quality Assurance

Clinical Sample Manager

Manager-Quality Assurance Auditor- GCP

Associate Director, Clinical Quality Assurance

Executive Director, Global Pharmacovigilance Operations, Quality & Compliance

Physical Security Design Manager

Clinical Quality Assurance Manager

Senior Manager Quality Audit Operations (Clinical Chart Validation)

Senior Manager Quality Compliance (Rare Disease)

vIOP Clinical Quality Manager

Manager, Clinical Review and Quality Assurance

Lead Clinical Research Associate/Trial Manager

Clinical Operations Coordinator

Senior Manager, Clinical Operations

Senior Clinical Program Manager

Sr. Manager/Associate Director, Clinical Monitoring Oversight

Senior Clinical Trial Manager (CTM)

Clinical Consulting Manager

Manager, Complex Clinical Review

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