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Remote Trackwise Jobs (NOW HIRING)

Orca Bio

Senior Specialist, Global QMS

Sacramento, CA · On-site +1

$90K - $120K/yr

MasterControl, ERP systems, Trackwise, etc.) ensuring alignment with regulatory and internal ... For remote-based positions, this range may vary based on your local market. Full-time employment ...

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How much do remote trackwise jobs pay per hour?

As of Sep 3, 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 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 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.

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 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.

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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 89% Full Time, 10% Contract, and 1% Nights. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $63,838 per year, or $30.7 per hour.

Senior Specialist, Global QMS

Orca Bio

Sacramento, CA • On-site, Remote

$90K - $120K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 14 days ago

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

The Senior Specialist, Global QMS will help implement Orca Bio’s global quality management system across all sites. This role will support and lead the internal audit program, supplier management program, and inspection readiness. This role will support the growth and expansion of the global quality program to support manufacturing of our cell therapy products. You will help establish, implement and maintain the audit program across Orca Bio sites to ensure compliance with GxP and regulatory expectations. Your role will support Orca Bios commercial readiness and ongoing clinical programs by managing and facilitating audits, resolving supplier-related quality issues and interacting with quality management teams at the site levels to ensure consistent application of quality systems across the organization.

Responsibilities:
  • Plan, schedule and execute internal audits across all sites and functions in accordance with the internal audit program.
  • Develop audit agenda, conduct interviews, review processes and generate audit reports.
  • Support the global Quality Management Review (QMR) process, ensuring timely data collection, analysis, and reporting to senior leadership.
  • Support the supplier qualification and management program, including risk assessments, supplier audits, and ongoing monitoring to ensure compliance with GxP requirements.
  • Drive global inspection management activities, ensuring cross-functional and site readiness for FDA, EMA, and other health authority inspections.
  • Provide oversight and guidance to site QMR administrators ensuring consistent quality system implementation across all Orca Bio sites.
  • Establish and monitor global QMS key performance indicators (KPIs), oversee trending of quality metrics, and ensure data-driven insights are used to improve quality systems and performance.
  • Partner with IT and business process owners to identify and implement QMS system enhancements, including defining requirements, driving prioritization and ensuring changes are validated and compliant.
  • Review, approve, and provide quality oversight for validation documentation (e.g., equipment qualification, computer system validation, process validation) for global enterprise systems (e.g. MasterControl, ERP systems, Trackwise, etc.) ensuring alignment with regulatory and internal requirements.
  • Collaborate with cross-functional and site leadership teams to drive continuous improvement initiatives, ensuring the QMS evolves in line with business needs and regulatory expectations.
Experience:
  • Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
  • Minimum 5+ years of relevant Quality Assurance or Quality Systems experience in a GxP-regulated environment, with at least 2-3 years in a leadership role.
  • Strong knowledge of global quality regulations and standards (FDA, EMA, ICH, ISO 9001, 21 CFR Parts 210/211/820, EU GMP).
  • Proven experience leading Quality Management Review, internal audit programs, supplier management processes, and validation oversight.
  • Demonstrated success in establishing and trending quality performance metrics and KPIs.
  • Experience supporting and/or administering electronic QMS systems and partnering with IT for system enhancements.
  • Experience working in a multi-site or global quality organization strongly preferred.
  • Excellent organizational, analytical, and communication skills, with the ability to influence and collaborate across functional and site boundaries.
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
 
Who we are
 
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
 
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
 
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
 
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
 
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
 
Notice to staffing firms
 
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.