Vendor & Third-Party Quality & Compliance Lead

Whereby; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Parexel is seeking a seasoned Quality & Third-Party Management professional to strengthen GMA V&TPM quality and compliance. The role focuses on QEs, QIs, deviations, CAPA, and audit readiness while coordinating with cross-functional teams and external partners to ensure inspection readiness.

The ideal candidate has a life science degree and pharma/CRO experience, with strong regulatory knowledge, risk management, and collaboration skills to mitigate third-party risks.

Qualifications

• Degree in a life science or healthcare-related discipline.
• Experience in Vendor & Third-Party Management, QA, Compliance, or similar role.
• Clinical Trial/Medical Affairs exp. in pharma or CRO.
• Experience with external suppliers and cross-functional stakeholders.
• Strong regulatory knowledge in Clinical Research.
• Knowledge of FDA/EMA/ICH guidelines.
• GxP, quality management systems and CAPA processes.

Responsibilities

• Manage Quality Events (QEs), Quality Issues (QIs), deviations, and related investigations.
• Support CAPA definition, implementation, tracking, effectiveness assessment, and closure.
• Assist audits and audit readiness activities.
• Ensure quality records and evidence are inspection-ready.
• Support third-party governance and Quality Risk Assessments (QRAs).
• Identify and escalate risks from third-party due diligence and oversight.
• Collaborate with stakeholders to oversee third-party activities.
• Lead continuous improvement of GMA V&TPM processes.

Skills

Quality Assurance

Vendor Management

Regulatory Compliance

GxP Knowledge

CAPA Management

Audit Readiness

Risk Assessment

Cross-functional Collaboration

Clinical Trials Knowledge

Education

Bachelor's degree in life science or healthcare

Tools

TPM tools

TPIAT

Job description

Parexel is seeking a seasoned Quality & Third-Party Management professional to strengthen GMA V&TPM quality and compliance. The role focuses on QEs, QIs, deviations, CAPA, and audit readiness while coordinating with cross-functional teams and external partners to ensure inspection readiness.

The ideal candidate has a life science degree and pharma/CRO experience, with strong regulatory knowledge, risk management, and collaboration skills to mitigate third-party risks.