Top 34 Biological quality assurance Jobs in Remote

Senior Manager, GCP Quality Assurance
Spyre Therapeutics —Remote
- $149,000 - $175,000 a year
- Remote
- 6 years
- Bachelor of Science
- Bachelor's degree
- Health insurance
- Retirement plan
Biological Safety Laboratory Project Manager
Parsons —Remote
- $125,100 - $225,200 a year
- Holidays
- Remote
- 7 years
- Microsoft Excel
- Construction site
- Wellness program
- Paid holidays
SCE Planning Project Manager
SummitWest Environmental —California
- $85,000 - $115,000 a year
- Full-time
- Remote
- Background check
- Management
- 5 years
- Paid training
- Health insurance
Quick Apply
Content Analyst II - Drug and Biological Policy
Cotiviti —Remote
- $100,000 - $135,000 a year
- Full-time
- Remote
- Writing skills
- Research
- 3 years
- Paid holidays
- Disability insurance
Project Manager
Info Incognito —Remote
- Part-time
- Remote
- HIPAA
- Mid-level
- Master's degree
- Flexible schedule
Quality Assurance SME
Tunnell Government Services —Washington, DC
- Remote
- Bachelor of Science
- Databases
- Bachelor's degree
Quick Apply
Senior Nonclinical Data Standards SME (CDISC SEND/SENDIG-AR)
Blu Omega —Remote
- $100,000 - $155,000 a year
- Full-time
- Remote
- 8 years
- Doctor of Philosophy
- Travel
- AD&D insurance
- Paid holidays
Senior GCP Auditor
ImmunityBio —Remote
- $145,500 - $160,000 a year
- Weekends as needed
- Writing skills
- Analysis skills
- Travel
- AD&D insurance
- Disability insurance
Data Manager
BRS —Remote
- Full-time
- Remote
- Computer Science
- Mid-level
- Windows
- Profit sharing
- Paid holidays
11d
Manager, Supplier Quality Management (Contract)
Allogene Therapeutics —Newark, CA
- $70 - $80 an hour
- Part-time
- Remote
- Engineering
- Mid-level
- Continuous improvement
- Health insurance
Quick Apply
Regulatory Affairs Specialist
Terumo —Lakewood, CO
- $80,200 - $100,300 a year
- Remote
- Mid-level
- Analysis skills
- Computer skills
- Wellness program
- Health insurance
2d
Senior Sterility Manager (Remote- US)
Teleflex —Templeton, MA
- $152,000 - $229,000 a year
- Remote
- 5 years
- Bachelor's degree
- Travel
- Disability insurance
- Health insurance
Medical Materiel Specialist II
Trinity Global Consulting —Andrews AFB, MD
- Full-time
- Remote
- 6 years
- Warehouse experience
- Senior level
- AD&D insurance
- Paid holidays
Quick Apply
QA Engineer, AI & Platform Infrastructure
ImmunityBio —Remote
- $135,000 - $150,000 a year
- Full-time
- Computer science
- Computer Science
- Office
- AD&D insurance
- Disability insurance
Scientific & Technical Support
Ocean Associates, Inc. —Remote
- $34 - $39 an hour
- Online Application
- English
- 3 years
- Master's degree
Quick Apply
2d
Senior Clinical Data Manager
Everest Clinical Research —Bridgewater, NJ
- $90,000 - $130,000 a year
- Remote
- Master's degree
- Bachelor's degree
- Senior level
- AD&D insurance
- Disability insurance
Quick Apply
Clinical Database Designer I
Everest Clinical Research —Bridgewater, NJ
- $50,000 - $90,000 a year
- Remote
- Computer science
- Computer Science
- Bachelor of Science
- AD&D insurance
- Disability insurance
Quick Apply
Clinical Monitoring Oversight Assessor - Contractor
Beaufort LLC —Virginia Beach, VA
- Contract
- Remote
- Management
- Mid-level
- 3 years
Online Membership Associate (Paid Ads Specialist)
Center for Biological Diversity —Tucson, AZ
- $57,000 - $65,000 a year
- Online Application
- Remote
- Mid-level
- 3 years
- Analysis skills
- 403(b) matching
- Health savings account
Quick Apply
Senior Scientist - Ecological Services
EHS Support, LLC —Remote
- Full-time
- 11+ years
- Master's degree
- Analysis skills
- Disability insurance
- Health insurance
Quick Apply

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biological quality assurance jobs near remote

Senior Manager, GCP Quality Assurance

Spyre Therapeutics -
Remote

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Job Details

$149,000 - $175,000 a year

Benefits

Health insurance
Unlimited paid time off
Retirement plan

Qualifications

Pharmaceutical company experience

Full Job Description

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary

Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The Senior Manager, GCP Quality will support Clinical Quality Assurance (CQA) activities across Spyre's clinical development programs, including the planning and execution of audits, management of quality issues and investigations, inspection readiness activities, and ongoing compliance oversight. This role requires strong knowledge of GCP regulations and quality systems, as well as the ability to collaborate effectively across functions to promote a culture of quality and continuous improvement.

The Senior Manager will partner closely with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, and external partners to ensure compliance with Spyre policies, procedures, and applicable global regulations and guidelines, including FDA, EMA, ICH, and other relevant regulatory requirements.

Key Responsibilities

Provide guidance and support on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP) requirements to clinical development teams, helping identify compliance risks and support implementation of appropriate mitigations.
Collaborate with internal stakeholders and external partners, including CROs, vendors, contract auditors, and investigator sites, to support quality oversight activities and promote consistent compliance across development programs.
Assist in the development and execution of risk-based audit plans for assigned programs and support inspection readiness initiatives.
Independently plan, conduct, manage, and report domestic and international audits of investigator sites, vendors, systems, and processes in accordance with applicable regulations and Spyre procedures.
Evaluate audit observations and quality issues for potential impact on participant safety, data integrity, and regulatory compliance.
Support investigations related to quality events, protocol deviations, compliance concerns, and potential GCP/GLP/GVP issues; assist with root cause analysis, CAPA development, implementation, and effectiveness verification.
Contribute to health authority inspection readiness activities and provide quality support during regulatory inspections and vendor audits.
Track, analyze, and communicate quality metrics and trends to support continuous improvement and risk management activities.
Partner with the broader Quality organization to identify opportunities for process improvements and harmonization across programs and functional areas.
Support the maintenance and continuous improvement of Spyre's Quality Management System (QMS), including procedures, training, CAPA, and audit management processes.
Maintain awareness of evolving regulatory requirements and industry best practices and help ensure appropriate implementation within the organization
Other duties as assigned

Ideal Candidate

BA/BS degree, preferably in biological sciences, or related field
Minimum of 6+ years of experience in the pharmaceutical, biotechnology or related health care industry
Minimum 4+ years of GCP-related Quality Assurance or relevant clinical trial and medical device experience
Strong knowledge of ICH-GCP, GLP, GVP, FDA regulations, EMA requirements, and other applicable global clinical development regulations and guidelines.
Experience conducting and/or managing GCP audits of investigator sites, vendors, CROs, and clinical systems.
Experience supporting regulatory inspections and inspection readiness activities preferred.
Working knowledge of Quality Management Systems, including CAPA, deviation management, risk assessment, change control, document management, and training systems.
Demonstrated ability to analyze regulations and apply quality and compliance principles in a practical, risk-based manner.
Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
Excellent written and verbal communication skills and the ability to effectively collaborate across functions and organizational levels.
Detail-oriented with strong problem-solving and critical-thinking capabilities.
Ability to work independently while also contributing effectively as a member of a collaborative team.
Travel may be required up to 15% of the time

What We Offer

Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $149,000 to $175,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.

Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain "@spyre.com." We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.

Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Apply Now

Refine Your Search

biological quality assurance jobs in remote

Senior Manager, GCP Quality Assurance

Biological Safety Laboratory Project Manager

SCE Planning Project Manager

Content Analyst II - Drug and Biological Policy

Project Manager

Quality Assurance SME

Senior Nonclinical Data Standards SME (CDISC SEND/SENDIG-AR)

Senior GCP Auditor

Data Manager

Manager, Supplier Quality Management (Contract)

Regulatory Affairs Specialist

Senior Sterility Manager (Remote- US)

Medical Materiel Specialist II

QA Engineer, AI & Platform Infrastructure

Scientific & Technical Support

Senior Clinical Data Manager

Clinical Database Designer I

Clinical Monitoring Oversight Assessor - Contractor

Online Membership Associate (Paid Ads Specialist)

Senior Scientist - Ecological Services

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