Senior Clinical QA Manager – Remote/Hybrid

United Pharma; North Carolina; Hybrid; USD 150,000 - 190,000; Part time

Job summary

United Pharma is seeking a Sr. Manager, Clinical Quality Assurance (contract) to serve as an internal expert on GCP, ICH, and global regulatory requirements, owning the standards, training, and oversight to keep clinical trials audit-ready.

The role leads SOP development, DOT eQMS Clinical module, and GCP training, providing QA oversight of CROs, vendors, and quality events throughout trial conduct.

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• 7–10 years of clinical quality and/or clinical operations experience in biotech/pharma/CRO.
• GCP/ICH knowledge, regulatory requirements, and QMS experience.

Responsibilities

• Review and oversee clinical QA documentation (SOPs, protocols, ICFs, reports, study-level docs).
• Collaborate with Clinical Operations to maintain GCP, ICH, and internal procedures compliance.
• Perform quality assessments of clinical processes, documentation, and outputs.
• Document quality activities, including deviations, CAPAs, and quality events.
• Define standards for SOP development, revision, and implementation.
• Serve as QA SME for assigned studies or programs.
• Provide proactive quality guidance to study teams and lead mitigation strategies.
• Lead audits of CROs, vendors, and investigator sites.
• Oversee vendor qualification and oversight activities.
• Ensure audit findings are tracked and addressed.
• Own investigations of quality events and deviations; drive root cause analysis and CAPA development.
• Track CAPAs and coordinate timely closure.
• Support inspection readiness activities (document review, gap assessments, back-room support).
• Partner with Clinical Operations to support quality across programs.
• Develop tools, templates, and quality metrics; contribute to QMS improvements.

Skills

7–10 years experience in clinical QA/0

GCP knowledge

ICH guidelines

FDA regulations

QMS experience

SOP development

Audit readiness

CAPA management

Problem solving

Communication skills

Organizational skills

Ownership mindset

Education

Bachelor's degree in a scientific or related discipline

Job description

United Pharma is seeking a Sr. Manager, Clinical Quality Assurance (contract) to serve as an internal expert on GCP, ICH, and global regulatory requirements, owning the standards, training, and oversight to keep clinical trials audit-ready.

The role leads SOP development, DOT eQMS Clinical module, and GCP training, providing QA oversight of CROs, vendors, and quality events throughout trial conduct.