- Location: Maryland, United States
- Type: Contract
- Job ID: 10471
- Work Setting: On-Site
- Posted: July 15, 2026
- Closing Date: August 2, 2027
- Tax Status: W2
Quality Associate
12- month Contract
Remote – EST Hours
Description
Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Quality Associate to support Global Clinical Quality Management (GQM) activities across multiple clinical studies. This role partners with cross-functional teams to ensure compliance with Good Clinical Practice (GCP), support inspection readiness, manage quality events, and promote continuous quality improvement throughout the clinical trial lifecycle.
Requirements
Qualifications
12- month Contract
Remote – EST Hours
Description
Our client, a Fortune 500 Pharmaceutical Company, has engaged GForce Life Sciences to provide a Quality Associate to support Global Clinical Quality Management (GQM) activities across multiple clinical studies. This role partners with cross-functional teams to ensure compliance with Good Clinical Practice (GCP), support inspection readiness, manage quality events, and promote continuous quality improvement throughout the clinical trial lifecycle.
Requirements
- Provide Quality oversight for multiple clinical studies from study planning through final reporting.
- Partner with Clinical Operations, Clinical Managers, Functional Areas, and other cross-functional stakeholders to support study quality activities.
- Participate in study team meetings and provide quality guidance and best practice recommendations.
- Support the identification, investigation, and resolution of quality issues, including protocol deviations, data integrity concerns, and potential Serious Breaches.
- Assist with escalation of significant quality issues to senior management as appropriate.
- Support risk assessments for the annual GCP audit plan, including identification of site and vendor audit needs.
- Prepare study documentation and provide support for internal and external GCP audits.
- Participate in vendor quality risk assessments and support development of the annual Vendor Audit Plan.
- Review CAPAs, audit findings, inspection responses, and other Quality Management System documentation.
- Support portfolio-wide inspection readiness activities, including mock inspections, interview preparation, and readiness assessments.
- Participate in the review and harmonization of controlled documents, including protocols, informed consent forms (ICFs), clinical study reports (CSRs), amendments, templates, and SOPs.
- Review and support Pharmacovigilance System Master File (PSMF) activities as assigned.
- Participate in Global Quality meetings and support continuous improvement initiatives.
- Complete ongoing GCP, ICH, and regulatory training requirements.
Qualifications
- Bachelor’s degree in Life Sciences or a related scientific discipline.
- Experience in the pharmaceutical, biotechnology, or CRO industry supporting Clinical Quality Assurance, GxP Compliance, Clinical Operations, or Regulatory Affairs.
- Strong knowledge of ICH GCP guidelines, FDA regulations, and global clinical trial requirements.
- Quality-related training or certifications, including Good Clinical Practice (GCP) and/or Root Cause Analysis (RCA), preferred.
- Experience supporting GCP inspections, inspection readiness, audit activities, CAPAs, deviations, and Quality Management System (QMS) processes.
- Strong analytical skills with the ability to identify trends, perform Root Cause Analysis (RCA), and support continuous process improvement.
- Excellent written, verbal, and interpersonal communication skills with the ability to collaborate across cross-functional teams.
- Strong organizational skills, attention to detail, and the ability to manage multiple priorities.
- Experience with TrackWise or another electronic Quality Management System (eQMS) preferred.