Manager, Quality Systems

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Manager, Quality Systems in United States. 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. Accountabilities:

• 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.

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).
• Experience with monoclonal antibodies or other biologics is preferred.
• 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).

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.

Why Apply Through Jobgether? We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Apply tot his job Apply To this Job