Senior Manager, Lab Systems and Operations - Remote

Overview

The Senior Manager, Lab Systems and Operations is responsible for ensuring the quality of assigned products, including pharmaceuticals and medical devices, while meeting business objectives and compliance regulations.

In Short

• Lead quality assurance for product transfers and organizational optimization.
• Develop global Product Quality Assurance strategy for various product types.
• Make key decisions on product quality and regulatory compliance.
• Maintain relationships with third-party manufacturers and internal teams.
• Communicate with external quality organizations to minimize compliance risks.
• Interface with audit teams for inspection readiness and audit plans.
• Manage quality assurance elements for new product launches.
• Support regulatory filings and marketing authorization dossiers.
• Develop monitoring metrics for product quality transfer processes.
• Lead small teams of quality professionals as needed.

Requirements

• Bachelor’s Degree in Life Science, Engineering, or related field.
• Minimum of 8 years of experience, with 3 years in Quality Assurance Operations Management.
• Comprehensive understanding of pharmaceutical technologies.
• Strong background in quality assurance/control and regulatory compliance.
• Experience with FDA and other regulatory interactions.
• Knowledge of third-party manufacturing requirements.
• Strong analytical and problem-solving skills.
• Ability to manage multiple complex tasks.
• Excellent interpersonal and leadership skills.

Benefits

• Equal opportunity employer committed to innovation and integrity.
• Opportunities for professional growth and development.
• Supportive work environment with a focus on community service.