QA Program Manager for Regulatory & Real-World Evidence

Headwater Science; Durham (NC); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work environment

Comprehensive health, dental, and eye/

401(k) with company match

Generous PTO and holidays

Paid parental leave

Job summary

Headwater Science in Durham, NC seeks a talented QA Program Manager to lead Regulatory Affairs and Quality Assurance, building and maintaining quality systems and ensuring compliance with regulatory standards.

You will oversee GDP, QMS, SOPs, and GCP/GPP processes; collaborate with cross-functional teams, manage internal SOP training, and support FDA readiness across the organization.

Qualifications

• Bachelor's degree in Life Sciences with 5+ years of relevant experience.
• Experience with pharmaceutical companies and CROs.
• Knowledge of evolving regulatory standards for Real World Evidence.
• Experience in real world evidence, registries, observational studies, third-party data analysis, or non-interventional research preferred.
• Ability to partner with multi-disciplinary teams through FDA requirements, agency inspections, vendor audits, and CAPA actions.

Responsibilities

• Serve as the regulatory affairs and quality assurance resource for all functional areas of the company, particularly regarding Real World Evidence.
• Act as a consultant on regulatory strategy matters.
• Lead risk assessments and audits of processes and systems.
• Oversee all aspects of the Quality Management System (QMS).
• Review vendor data and quality records for conformance to GDP.
• Lead the development and management of SOPs and WIs across the company.
• Support functional teams in SOP/WI development for their areas.
• Develop and maintain GCP and GPP compliance processes to control quality of work.
• Maintain knowledge of GCP/GPP guidance and inform management of changes and issues.
• Manage the internal SOP training program for all employees.

Skills

Regulatory affairs

Quality assurance

GxP knowledge

Real World Evidence

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

Headwater Science in Durham, NC seeks a talented QA Program Manager to lead Regulatory Affairs and Quality Assurance, building and maintaining quality systems and ensuring compliance with regulatory standards.

You will oversee GDP, QMS, SOPs, and GCP/GPP processes; collaborate with cross-functional teams, manage internal SOP training, and support FDA readiness across the organization.