Senior Compliance Manager - Remote

Overview

The Senior Compliance Manager will oversee all validation activities, ensuring compliance with regulatory guidelines and internal quality standards. This role will lead cross-functional teams to implement and maintain validation processes for equipment, systems, and software critical to the organization.

In Short

• Develop and execute validation deliverables, including validation plans and protocols.
• Oversee compliance with FDA 21 CFR Part 11 and ISO standards.
• Act as a subject matter expert for validation engineers.
• Collaborate with teams to align validation requirements with timelines.
• Conduct risk assessments and remediation plans for validation projects.
• Ensure lifecycle management of validated systems.
• Lead preparation for internal and external audits.
• Drive process improvements for validation activities.
• Mentor team members on validation processes.
• Manage resources, budgets, and timelines for validation projects.

Requirements

• Bachelor's degree in Engineering or Life Sciences.
• 10+ years of experience in validation in a regulated environment.
• Expertise in validation methodologies and regulatory compliance.
• Strong knowledge of GxP regulations.
• Strong leadership and problem-solving skills.
• Experience managing large-scale validation projects.
• Familiarity with emerging trends such as CSA.

Benefits

• Equal employment opportunities without discrimination.
• Environmental consciousness and safe practices.
• Use of modern office equipment.
• Flexible working hours during peak cycles.
• Opportunities for travel.