GxP Validation & QA Systems Lead

Planet Pharma; Alameda (CA); On-site; USD 77,000 - 94,000; Full time

Job summary

Planet Pharma seeks a QA Manager for Systems and Process Excellence to oversee CSV, Data Integrity, and QMS activities in a regulated, GxP environment. The role ensures system compliance, manages access, changes, deviations, and CAPAs, and supports continuous system improvements with cross-functional teams.

The ideal candidate has a Bachelor’s in science and at least 7 years’ related experience, including validated applications.

Qualifications

• Bachelor’s degree in science or related field with 7+ years in regulated environments.
• Experience implementing GxP computerized systems and maintaining validated state.
• Strong process improvement, negotiation and cross-functional collaboration.

Responsibilities

• Support CSV/DI programs and QMS activities across System and Business Owners.
• Analyze user requests and design solutions to improve processes and automate where possible.
• Lead UAT, PQ and validation testing and review deliverables (URS, FS, IQ/OQ/PQ).
• Generate metrics and reports to demonstrate data quality and compliance.
• Collaborate with internal/external audits and inspections.

Skills

process improvement

negotiation skills

communication skills

team player

System Administration knowledge

Veeva Platform knowledge

Education

Bachelor’s degree in science or related field

Tools

Veeva Platform (Quality QMS)

QDocs

SaaS systems

QMS

Job description

Planet Pharma seeks a QA Manager for Systems and Process Excellence to oversee CSV, Data Integrity, and QMS activities in a regulated, GxP environment. The role ensures system compliance, manages access, changes, deviations, and CAPAs, and supports continuous system improvements with cross-functional teams.

The ideal candidate has a Bachelor’s in science and at least 7 years’ related experience, including validated applications.