Manager, Quality Systems

Jobgether

1d • Remote

About The Position

We are seeking an experienced Manager of Quality Systems to lead and maintain a comprehensive Quality Management System in a dynamic biotechnology environment. This role ensures regulatory compliance while supporting innovation and operational flexibility across clinical, CMC, and supply chain functions. You will manage document control, training programs, and quality metrics to promote consistent excellence in quality operations. The position involves collaboration across multiple departments, mentoring team members, and providing guidance on quality processes and system improvements. The ideal candidate thrives in a fast-paced, high-impact environment and balances independent execution with teamwork to drive continuous improvement. Remote work is supported with periodic in-person engagement for key meetings and initiatives.

Requirements

• Bachelor’s degree in Life Sciences or related field, with a minimum of 5 years’ experience in a GMP-regulated biotech or pharmaceutical environment.
• In-depth knowledge of GMP regulations, quality systems, quality assurance, and quality control processes.
• Proficiency with Veeva electronic Quality Management Systems (Veeva Vault or Veeva Quality Basics).
• Strong verbal and written communication skills with the ability to interact with diverse stakeholders, including senior management and regulatory agencies.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Nice To Haves

• Experience with monoclonal antibodies or other biologics is preferred.

Responsibilities

• Manage and maintain a compliant Document Control System, overseeing creation, review, approval, and archiving of GxP documents.
• Lead the training program, including onboarding, offboarding, and reporting on compliance metrics.
• Process and track Quality Management System items, including Change Control, Deviations, and CAPAs.
• Generate and report quality system metrics, assisting in Quality Management Reviews.
• Oversee periodic document review to ensure compliance with established schedules.
• Train and mentor staff on eQMS processes, system usage, and quality procedures.
• Collaborate with functional teams to support quality initiatives and process improvements.

Benefits

• Competitive compensation with performance bonus and equity grant opportunities.
• Comprehensive health, welfare, and retirement benefits.
• Unlimited PTO with two one-week company-wide shutdowns annually.
• Professional development and continuing education support.
• Remote work environment with periodic in-person meetings.
• Opportunity to contribute to innovative therapies and shape company culture in a growing biotech company.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager