Top 2462 Regulatory compliance Jobs in Austin, Tx

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Compliance & Regulatory Affairs Coordinator
CSI Aviation, Inc. —Austin, TX
- $28 - $38 an hour
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- HIPAA
- Health insurance
- Dental insurance
Quick Apply
5d
Environmental Health & Safety Coordinator
Trumpf —Austin, TX
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
Site Operations Quality Manager
ClearCorrect —Round Rock, TX
- $115,000 - $125,000 a year
- Full-time
- 5 years
- Engineering
- Supervising experience
- Health insurance
- Dental insurance
Senior Healthcare Compliance Audit Specialist
Clinical Pathology Laboratories, Inc —Austin, TX
- Full-time
- HIPAA
- Mid-level
- Office
- Paid holidays
- Health insurance
Professional Education Compliance Lead
Abbott Laboratories —Austin, TX
- $86,700 - $173,300 a year
- Full-time
- Marketing
- 5 years
- Bachelor of Science
- Health insurance
- Tuition reimbursement
Investigator, Extended Workforce Investigations (Fixed-Term Contract)
Google —Austin, TX
- $141,000 - $206,000 a year
- Full-time
- 7 years
- Writing skills
- Office
- Paid holidays
- Disability insurance
4d
Program Manager, Regulatory Compliance, WWGS - Facility Operations Support
Amazon.com Services LLC —Austin, TX
- $74,200 - $129,800 a year
- Full-time
- Mid-level
- 3 years
- SQL
- AD&D insurance
- Health insurance
11d
Compliance Officer
SPECIALTY RX OF CENTRAL TEXAS LLC —Austin, TX
- $120,000 - $130,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
14d
Regulatory Compliance Specialist
WhiteWater Midstream —Austin, TX
- Full-time
- 5 years
- Office
- Microsoft Office
- AD&D insurance
- Health insurance
Quick Apply
Site Regulatory/ Data Coordinator
Sarah Cannon Research Institute —Austin, TX
- Full-time
- Microsoft Outlook
- Writing skills
- Mid-level
Program Manager, Enterprise Risk Management (Compliance)
Google —Austin, TX
- $136,000 - $197,000 a year
- Full-time
- 7 years
- Office
- SQL
- Paid holidays
- Disability insurance
Property Compliance Analyst
Novogradac & Company —Austin, TX
- $64,000 - $87,000 a year
- Weekends as needed
- Hybrid work
- Microsoft Excel
- Writing skills
- Research
- Profit sharing
- Paid holidays
Regulatory Analyst (Midland, TX)
University of Texas System —Austin, TX
- Urgently hiring
- Background check
- Bachelor of Science
- Mid-level
- Retirement plan
Senior Product Compliance Manager
Wise Australia Investments —Austin, TX
- $134,000 - $170,000 a year
- 5 years
- Office
- Travel
Site Regulatory/ Data Coordinator
McKesson —Austin, TX
- Microsoft Outlook
- Writing skills
- Mid-level
Compliance Coordinator
Mayfair Management Group, LP —Austin, TX
- $28 - $29 an hour
- Mid-level
- Bachelor's degree
- Business Administration
Quick Apply
Junior QA Engineer
Austin Capital Bank —Austin, TX
- $65,000 - $85,000 a year
- Full-time
- Hybrid work
- Office
- Continuous improvement
- JavaScript
Quick Apply
OFAC and Sanctions Analyst
eBay Inc. —Austin, TX
- $71,600 - $123,400 a year
- Full-time
- Mid-level
- 2 years
- Communication skills
- Paid time off
- Parental leave
Risk Manager, Compliance Second Line of Defense, Global Operations Enterprise Services
Amazon.com LLC —Austin, TX
- $83,200 - $145,500 a year
- Full-time
- Master's degree
- Bachelor's degree
- Children
- AD&D insurance
- Health insurance

I want to receive the latest job alert for regulatory compliance in austin, tx

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory compliance jobs near austin, tx

Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Life insurance

Qualifications

Regulatory inspections
Clinical research
Clinical research audit management
Quality control audit
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
Bachelor's degree
Laboratory regulatory affairs
Attention to detail
Quality improvement
Vendor communication
Organizational skills
Training & development
Quality assurance experience within healthcare

Full Job Description

Job description:

XBiotech USA, Inc. is currently seeking an experienced Clinical Quality Assurance (QA) Specialist to join our team in Austin, TX.

XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.

Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.

Position Summary:

The Clinical QA Specialist provides strategic QA oversight across clinical development programs of XBiotech, leverages expertise to ensure clinical research operations comply with regulatory standards (ICH-GCP, FDA, EMA, etc.) and internal policies, focusing on data integrity, patient safety and process improvements.

Key Responsibilities:

Compliance and Oversight:

· Develop and maintain the Quality Management System (QMS) and SOPs, to ensure compliance with Good Clinical Practice (GCP), and Good Laboratory Practices (GLP).

· Review and approve essential clinical trial documentation (protocols, reports, SOPs, etc.) for accuracy and compliance.

· Provide QA oversight for Phase I–III clinical trials, ensuring compliance with protocols, GCP, and applicable regulations throughout the trial lifecycle.

· Evaluate and manage protocol deviations and serious breaches in accordance with regulatory requirements.

· Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to embed quality throughout clinical development.

CAPA and Risk Management:

· Manage the development, implementation and effectiveness of Corrective and Preventive Actions (CAPA).

· Perform root cause analysis for compliance issues. Conduct risk assessments and implement mitigation strategies.

· Track issues to resolution and trend data for systemic improvements.

· Proactively identify, report and mitigate risks within clinical research processes.

Audit and Inspection Readiness:

· Plan and execute QA audits of clinical trial sites, vendors, CROs, and internal processes.

· Conduct vendor qualification audits and ongoing oversight of third-party providers.

· Review and trend Audit Reports to propose process improvements.

· Prepare for and host regulatory inspections, ensuring all documentation is ready. Review audit findings and ensure timely resolution.

Training:

· Provide training on GCP and quality standards to staff and foster a culture of quality.

QUALIFICATIONS/EXPERIENCE REQUIRED:

· Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Master’s degree preferred.

· 5-7+ years of clinical research experience, including QA experience (3+ years) is required.

· Experience with regulatory inspections (FDA/EMA) preferred.

· Demonstrated experience planning and conducting clinical site and vendor audits, and hosting regulatory audits.

· Demonstrated competencies in GCP and regulatory compliance knowledge

· Proficiency with Electronic Data Capture (EDC) and eTMF systems.

· Excellent written and verbal communication skills.

· Must be a self-motivated and detail-oriented person who works well in a team setting.

· Must be willing to learn and adapt to changes in a fast-paced working environment.

·Must be able to multitask and have strong organizational skills.

Benefits:

401(k)
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical research: 5 years (Required)
QA: 3 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

regulatory compliance jobs in austin, tx

Clinical QA Specialist

Compliance & Regulatory Affairs Coordinator

Environmental Health & Safety Coordinator

Site Operations Quality Manager

Senior Healthcare Compliance Audit Specialist

Professional Education Compliance Lead

Investigator, Extended Workforce Investigations (Fixed-Term Contract)

Program Manager, Regulatory Compliance, WWGS - Facility Operations Support

Compliance Officer

Regulatory Compliance Specialist

Site Regulatory/ Data Coordinator

Program Manager, Enterprise Risk Management (Compliance)

Property Compliance Analyst

Regulatory Analyst (Midland, TX)

Senior Product Compliance Manager

Site Regulatory/ Data Coordinator

Compliance Coordinator

Junior QA Engineer

OFAC and Sanctions Analyst

Risk Manager, Compliance Second Line of Defense, Global Operations Enterprise Services

I want to receive the latest job alert for regulatory compliance in austin, tx

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected