Quality Operations Program Manager - Document Control

📋 Description

• Own lifecycle management of quality documents and records
• Administer and optimize the eDMS, including user management
• Oversee regulated activities, process validation, and product releases
• Interpret regulatory requirements and guide quality systems
• Create metrics to measure domain system effectiveness
• Ensure process alignment with GxP and ISO quality frameworks

🎯 Requirements

• BS/BA in Science, Information Management, Engineering, or equivalent
• 5+ years in a regulated quality role in Life Sciences
• Experience with QMS (docs, training, change control, CAPA)
• Experience with eDMS and/or eQMS
• GxP and quality frameworks (21 CFR 11, ICH Q10, QSR; ISO 9001)
• Strong process mapping, problem-solving, and communication

🎁 Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program