Senior Specialist, Quality Management System - R&D - Remote

Overview

The Senior Specialist (SS) Quality Management System Research and Development Procedural Document Management (RDPDM) promotes and supports the efficient change control for Research and Development (R&D) procedures, ensuring compliance with internal and GxP standards.

In Short

• Promote and support change control for R&D procedures.
• Ensure compliance with internal and GxP standards.
• Manage change control records within ETQ.
• Collaborate with R&D colleagues on change control principles.
• Monitor change control records for completeness.
• Develop and communicate training on change control procedures.
• Stay informed on industry standards and regulations.
• Work independently under QMS Director supervision.
• Contribute to quality strategy and systems management.
• Utilize excellent analytical and communication skills.

Requirements

• BS degree in Health Sciences or relevant certification.
• 2-3 years of experience in managing change control.
• Experience in pharmaceutical/medical device R&D.
• Understanding of international standards for change control.
• Preferred experience in ETQ software.
• Strong analytical, collaborative, and communication skills.
• Ability to oversee processing of large volumes of records.
• Knowledge of procedural document hierarchy in pharma.
• Ability to develop and deploy effective system trainings.
• Demonstrated leadership behaviors.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, dental, and vision coverage.