Remote Site Quality & Compliance Lead (EST Hours)

Spectraforce Technologies, Inc.; Raleigh (NC); Remote; USD 130,000 - 170,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Site Quality and Compliance Lead to drive quality activities and inspection readiness for US/International clinical programs. The role focuses on planning, delivering training, and coordinating quality initiatives across CD&O with Legal and Med/RA teams.

Remote role (EST hours) with responsibility for CAPA, governance, and ensuring compliance with FDA/ICH/GCP. Bachelor's in life sciences preferred; experience in pharmaceutical quality is expected.

Qualifications

• Bachelor's degree in life sciences highly preferred.
• Experience in pharmaceutical quality and regulatory compliance.
• Strong knowledge of FDA/ICH/GCP regulations.

Responsibilities

• Develop and deliver just in time training for US CDO.
• Plan and coordinate training initiatives to meet timelines and budgets.
• Collaborate with US CDO, Legal, and Med/RA to drive quality in clinical operations.
• Assist in sponsor inspections and internal audits addressing findings.
• Lead CAPA development and quality metrics reporting.

Skills

Pharma lifecycle

Regulatory requirements

Technology trends

Project management

Education

Bachelor's degree in life sciences

Job description

Spectraforce Technologies, Inc. is seeking a Site Quality and Compliance Lead to drive quality activities and inspection readiness for US/International clinical programs. The role focuses on planning, delivering training, and coordinating quality initiatives across CD&O with Legal and Med/RA teams.

Remote role (EST hours) with responsibility for CAPA, governance, and ensuring compliance with FDA/ICH/GCP. Bachelor's in life sciences preferred; experience in pharmaceutical quality is expected.