remote
Global Quality System Developer and Validation Analyst - Colgate Palmolive
Software Engineer
Lead the design, implementation, and validation of global quality systems, ensuring compliance with GxP and regulatory standards while driving continuous improvement through data‑driven insights and automation.
About the role
Key Responsibilities
- Develop, maintain, and validate quality system modules across multiple product lines, ensuring alignment with GxP and FDA requirements.
- Lead root cause analysis and corrective action initiatives, translating findings into robust SOPs and process improvements.
- Collaborate with cross‑functional teams to design and execute validation plans, including installation, operational, and performance qualification.
- Utilize SQL and Python to extract, analyze, and report on quality metrics, supporting data‑driven decision making.
- Document validation deliverables, maintain audit trails, and prepare for internal and external audits.
Requirements
- BS/BA in Life Sciences, Engineering, or related field; advanced degree preferred.
- 5+ years of experience in quality system development and validation within regulated industries.
- Strong knowledge of GxP, FDA 21 CFR Part 11, and ISO 13485/9001 standards.
- Proficiency in SQL and Python for data manipulation and reporting.
- Excellent written and verbal communication skills, with a proven ability to influence stakeholders.
Skills
data analysissqlpython