Rad Hires
Quality Assurance (QA) Coordinator
Location:
Philippines (Remote)
Schedule:
Full-time • Requires consistent overlap with U.S. Pacific Time
Level:
Mid-Level • Individual Contributor
About the Company We are representing a growing organization that operates at the intersection of
clinical research services (CRO)
and
clinical trial technology . The company builds and supports a modern software platform used in clinical studies and also provides CRO services to pharmaceutical, biotech, medical device, and research partners.
Because they work in a
highly regulated, audit-heavy environment , their Quality Management System (QMS) is a core part of the business. They are seeking a QA Coordinator to centralize and strengthen quality operations across the company.
The team is
small, collaborative, detail-oriented , and values people who are proactive, organized, and not afraid to speak up or remind others of deadlines.
About the Role This is a newly created role designed to support the QA Director by owning day-to-day quality system activities. The QA Coordinator will manage recurring QMS processes, maintain documentation and records, support audits, and ensure the organization is consistently meeting regulatory expectations.
Although the role has
no direct reports , it requires someone who can
coordinate across teams, follow up consistently, and mobilize people to complete required tasks (training, documentation, etc.) .
This position will be supported through an onboarding process and will work closely with the QA Director, Operations, and other cross-functional teams.
Key Responsibilities Quality System & Compliance
Coordinate supplier qualification and requalification
Support CAPA management, nonconformity tracking, and complaint handling
Assist in internal, external, and regulatory audit preparation
Organize audit documentation, track findings, and follow up on corrective actions
Maintain and report key quality metrics and KPIs
Ensure organization-wide adherence to SOPs and regulatory standards
Training & Qualification Tracking
Assign and track department and role-based training
Maintain complete training records and monitor expirations
Coordinate qualification reviews with managers
Work with HR and department leads to ensure no training gaps
Document Control
Issue, revise, retire, and distribute SOPs and controlled documents
Maintain clean, version-controlled, audit-ready files
Prepare documentation packages for inspections
Oversee record archiving and retention per company policy.
Required Qualifications
3+ years of experience
in a regulated environment (CRO, clinical research, pharmaceuticals, medical device, hospital systems, or regulated technology)
Strong experience in quality processes: CAPAs, document control, audits, supplier qualification
Experience with QMS or document control platforms (e.g., Kivo or similar)
Strong written and spoken
English
(critical requirement)
Experience working with SOPs and quality documentation
Highly organized, detail-oriented, proactive, and comfortable coordinating across teams
Ability to work part of the schedule in
U.S. Pacific hours.
Nice to Have
Knowledge of GCP, HIPAA, FDA regulations
Experience preparing for audits or regulatory inspections
Experience in small, fast-paced, or early-stage organizations
Prior work in CRO operations or hospital/healthcare systems.
Work Environment & Additional Notes
Fully remote from the Philippines
Monday–Friday schedule; flexibility in working hours but requires consistent overlap with U.S. PT
No travel required
Company provides laptop and IT security setup.
Strong culture of collaboration, openness, and proactive communication
Team appreciates people who speak up, identify problems early, and help improve processes
#J-18808-Ljbffr
Philippines (Remote)
Schedule:
Full-time • Requires consistent overlap with U.S. Pacific Time
Level:
Mid-Level • Individual Contributor
About the Company We are representing a growing organization that operates at the intersection of
clinical research services (CRO)
and
clinical trial technology . The company builds and supports a modern software platform used in clinical studies and also provides CRO services to pharmaceutical, biotech, medical device, and research partners.
Because they work in a
highly regulated, audit-heavy environment , their Quality Management System (QMS) is a core part of the business. They are seeking a QA Coordinator to centralize and strengthen quality operations across the company.
The team is
small, collaborative, detail-oriented , and values people who are proactive, organized, and not afraid to speak up or remind others of deadlines.
About the Role This is a newly created role designed to support the QA Director by owning day-to-day quality system activities. The QA Coordinator will manage recurring QMS processes, maintain documentation and records, support audits, and ensure the organization is consistently meeting regulatory expectations.
Although the role has
no direct reports , it requires someone who can
coordinate across teams, follow up consistently, and mobilize people to complete required tasks (training, documentation, etc.) .
This position will be supported through an onboarding process and will work closely with the QA Director, Operations, and other cross-functional teams.
Key Responsibilities Quality System & Compliance
Coordinate supplier qualification and requalification
Support CAPA management, nonconformity tracking, and complaint handling
Assist in internal, external, and regulatory audit preparation
Organize audit documentation, track findings, and follow up on corrective actions
Maintain and report key quality metrics and KPIs
Ensure organization-wide adherence to SOPs and regulatory standards
Training & Qualification Tracking
Assign and track department and role-based training
Maintain complete training records and monitor expirations
Coordinate qualification reviews with managers
Work with HR and department leads to ensure no training gaps
Document Control
Issue, revise, retire, and distribute SOPs and controlled documents
Maintain clean, version-controlled, audit-ready files
Prepare documentation packages for inspections
Oversee record archiving and retention per company policy.
Required Qualifications
3+ years of experience
in a regulated environment (CRO, clinical research, pharmaceuticals, medical device, hospital systems, or regulated technology)
Strong experience in quality processes: CAPAs, document control, audits, supplier qualification
Experience with QMS or document control platforms (e.g., Kivo or similar)
Strong written and spoken
English
(critical requirement)
Experience working with SOPs and quality documentation
Highly organized, detail-oriented, proactive, and comfortable coordinating across teams
Ability to work part of the schedule in
U.S. Pacific hours.
Nice to Have
Knowledge of GCP, HIPAA, FDA regulations
Experience preparing for audits or regulatory inspections
Experience in small, fast-paced, or early-stage organizations
Prior work in CRO operations or hospital/healthcare systems.
Work Environment & Additional Notes
Fully remote from the Philippines
Monday–Friday schedule; flexibility in working hours but requires consistent overlap with U.S. PT
No travel required
Company provides laptop and IT security setup.
Strong culture of collaboration, openness, and proactive communication
Team appreciates people who speak up, identify problems early, and help improve processes
#J-18808-Ljbffr