Global PV QA Lead: Audits, CAPAs & Inspection Readiness

Lancesoft; Cambridge (MA); On-site; USD 270,000 - 330,000; Full time

Job summary

Alnylam is seeking a Senior PV QA Auditor to provide quality oversight for the global postmarketing PV system. The role focuses on auditing, CAPA management, deviations, and QA operations in a fast-paced environment.

You will support GVP audits, inspections readiness, and vendor oversight while collaborating with cross-functional PV teams to ensure regulatory compliance and continuous improvement.

Qualifications

• Minimum Bachelor’s degree, preferably in life sciences.
• 10+ years in PV QA with auditing and QA operations.
• Strong understanding of GVP requirements and PV regulations.

Responsibilities

• Provide Quality oversight of Alnylam's global postmarketing PV system.
• Support development and execution of the global GVP audit program.
• Conduct audits of licensing partners, vendors, affiliates, internal teams and service providers.
• Evaluate Quality Events, deviations, root cause analyses, and CAPAs.
• Support risk-based audit strategy and maintain PV audit universe and schedule.
• Provide audit, CAPA, and supplier data for the PSMF.
• Develop and maintain audit processes, tools, and quality metrics.
• Support PV/PMS inspection readiness and inspection management.
• Provide Quality oversight of PV/PMS vendors.
• Support Quality Agreements, KQIs, vendor qualification, and audits.
• Support GVP QA training and process improvement initiatives.

Skills

Auditing

QA operations

PV regulations

GVP experience

CAPA

Root cause analysis

Education

Bachelor's degree in life sciences

Tools

Veeva

Quality Vault

Quality systems

Job description

Alnylam is seeking a Senior PV QA Auditor to provide quality oversight for the global postmarketing PV system. The role focuses on auditing, CAPA management, deviations, and QA operations in a fast-paced environment.

You will support GVP audits, inspections readiness, and vendor oversight while collaborating with cross-functional PV teams to ensure regulatory compliance and continuous improvement.