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Remote Trackwise Jobs (NOW HIRING)

Vaxcyte

Sr. Manager, Regulatory Affairs

San Carlos, CA · On-site +1

$183K - $194K/yr

Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). * Ability to meet multiple ... US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or ...

System One

Supplier Quality Engineer

Portage, MI · Remote

$55 - $60/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Remote - offsite (Michigan, Indiana, Ohio, Illinois preferred) Responsibilities * Negotiate ... Experience with audit processes, non-conformance management, and TrackWise. * Proficiency in FMEA ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). * Ability to meet multiple ... Remote Compensation: The compensation package will be competitive and includes comprehensive ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Hybrid - onsite and remote Overview Join a collaborative and innovation-driven medical technology ... system, Trackwise. * Support execution and analysis of manufacturing related complaint ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Hybrid - onsite and remote Overview Join a collaborative and innovation-driven medical technology ... system, Trackwise. * Support execution and analysis of manufacturing related complaint ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Hybrid - onsite and remote Overview Join a collaborative and innovation-driven medical technology ... system, Trackwise. * Support execution and analysis of manufacturing related complaint ...

Cooper Companies

Data Engineer Lead- PMS & QA

Trumbull, CT · On-site +1

  • Medical

  • Retirement

  • PTO

Trumbull, CT (on-site), Livingston, NJ (on-site) or Remote in US (if not residing in NY-metro area ... Trackwise, Veeva) and understanding build requirements when converting to new eQMS. * Ability to ...

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Remote Trackwise information

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$25

$30

$34

How much do remote trackwise jobs pay per hour?

As of Aug 13, 2026, the average hourly pay for remote trackwise in the United States is $30.69, according to ZipRecruiter salary data. Most workers in this role earn between $30.05 and $30.05 per hour, depending on experience, location, and employer.

What is the difference between Remote Trackwise vs Remote Trackwise Administrator?

AspectRemote TrackwiseRemote Trackwise Administrator
Primary RoleManaging and configuring Trackwise software for quality and complianceOverseeing system administration, user access, and data integrity within Trackwise
Required SkillsKnowledge of Trackwise platform, quality processes, and regulatory standardsSystem administration, user management, troubleshooting, and basic IT skills
Work EnvironmentRemote, often within pharmaceutical or biotech industriesRemote, typically in quality assurance or IT support teams
CertificationsOften requires knowledge of GxP, 21 CFR Part 11, and software-specific trainingIT certifications or training in system administration beneficial

Remote Trackwise professionals focus on configuring and supporting the Trackwise platform, while Remote Trackwise Administrators handle system management, user access, and troubleshooting. Both roles are essential in quality compliance environments, with overlapping skills but distinct responsibilities.

What is a Remote TrackWise?

A Remote Trackwise job typically involves managing and supporting the TrackWise Quality Management System (QMS) software from a remote location. Professionals in this role are responsible for configuring, maintaining, and troubleshooting the TrackWise application, which is widely used in regulated industries like pharmaceuticals and life sciences to track quality and compliance issues. Working remotely, they collaborate with cross-functional teams to ensure the system meets business and regulatory requirements, handle user support, and may assist in process improvement initiatives. Strong knowledge of TrackWise software, quality management processes, and remote communication tools are essential for success in this role.

What are some common challenges faced by Remote TrackWise specialists, and how can they be addressed?

Remote TrackWise specialists often encounter challenges such as coordinating with geographically dispersed teams, ensuring data integrity, and adapting to varying client configurations. Effective communication through virtual collaboration tools and regular check-ins helps bridge distance gaps. Staying updated on TrackWise best practices and leveraging detailed documentation can also minimize errors and support consistent quality management. Building strong relationships with IT and quality assurance teams is key to overcoming technical or process-related hurdles.

What are the key skills and qualifications needed to thrive as a Remote TrackWise specialist?

To thrive as a Remote TrackWise Specialist, you need expertise in quality management systems (QMS), experience with TrackWise software, and often a background in life sciences or regulated industries. Familiarity with TrackWise configuration, workflow design, and related regulatory standards (such as FDA or ISO requirements) is typically required, along with knowledge of SQL or other database tools. Strong problem-solving abilities, attention to detail, and effective remote communication skills set top performers apart in this role. These competencies ensure efficient management of quality processes, regulatory compliance, and seamless collaboration with distributed teams.
More about Remote Trackwise jobs
What cities are hiring for Remote Trackwise jobs? Cities with the most Remote Trackwise job openings:
What are the most commonly searched types of Trackwise jobs? The most popular types of Trackwise jobs are:
What states have the most Remote Trackwise jobs? States with the most job openings for Remote Trackwise jobs include:
What job categories do people searching Remote Trackwise jobs look for? The top searched job categories for Remote Trackwise jobs are:
Remote Trackwise jobs near you
Infographic showing various Remote Trackwise job openings in the United States as of August 2026, with employment types broken down into 85% Full Time, 1% Temporary, 13% Contract, and 1% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $63,838 per year, or $30.7 per hour.

Sr. Manager, Regulatory Affairs

Vaxcyte

San Carlos, CA • On-site, Remote

$183K - $194K/yr

Full-time

Re-posted 27 days ago

Job description

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.

Essential Functions:
  • Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
  • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
  • Manage preparation of responses to queries from regulatory authorities.
  • Ensure conformance to commitments made with various regulatory agencies.
  • Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
  • Manage coordination, preparation, and timely submission of regulatory documents and filings.
  • Review and approve change controls related to proposed product/process changes and asses their impact against regulatory requirements.
  • Cultivate productive working relationships with the Regulatory team and other departments.
  • Coordinate responses to CMC-related queries from Health Authorities.
Requirements: 
  • Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
  • 9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
  • Prior experience preparing/authoring CMC DS sections:
    • BLA highly preferred.
    • IND highly preferred.
    • IMPD.
  • Prior development or manufacturing experience is a plus.
  • Experience with module 3.2S and 3.2P.
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
  • Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte's achievement of business objectives.
Reports to: Executive Director, Regulatory CMC 
 
Location: US - Remote
 
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): 
Remote
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary.
 
Relocation: 
This role is not eligible for relocation assistance. 
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About Vaxcyte

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

San Carlos, CA, US

Year founded

2013

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