Senior Manager, Quality Systems
Location: Lexington, MA -- Onsite 4+ days per week
Employment Type: Contract-to-Hire
Industry: Pharmaceutical / Biotechnology
Contract Duration: 6 months with strong potential for permanent conversion
Position Overview
We are seeking an experienced Senior Manager, Quality Systems to own, maintain, configure, and continuously improve a global electronic Quality Management System (eQMS) within a regulated pharmaceutical environment.
This is a hands-on individual contributor leadership role for someone who can serve as the technical and functional subject matter expert for Quality Systems. You will be responsible for system administration, configuration, workflow optimization, document control, validation, reporting, training, and ongoing enhancements.
The ideal candidate is someone who is comfortable wearing multiple hats, working independently, partnering across departments, and taking ownership of Quality Systems initiatives from requirements through implementation.
Key Responsibilities
- Serve as the primary administrator and subject matter expert for the organization's eQMS platform
- Configure, maintain, and continuously improve eQMS workflows, modules, and functionality
- Lead system enhancements, implementations, upgrades, releases, and lifecycle management
- Design and optimize workflows to improve Quality processes and operational efficiency
- Manage electronic document control processes, including routing, approvals, version control, archival, and retrieval
- Partner with Quality, IT, Validation, and business stakeholders to translate requirements into effective system solutions
- Support User Acceptance Testing (UAT), Computer System Validation (CSV), change control, and periodic system reviews
- Develop and maintain Quality Systems metrics, dashboards, reporting, and process analytics
- Identify opportunities for workflow automation and technology-enabled process improvements
- Develop SOPs, system documentation, training materials, and user support resources
- Deliver system training and support effective user adoption
- Support regulated training curricula and associated Quality Systems processes
- Assist with inspection readiness and provide system documentation, reporting, and demonstrations as needed
- Manage multiple Quality Systems projects and initiatives simultaneously
- Serve as a trusted advisor and technical resource to cross-functional stakeholders
- Stay current with regulatory requirements, industry trends, and Quality Systems best practices
Required Qualifications
- Bachelor's degree or equivalent experience
- 5-10+ years of hands-on experience in Quality Systems, eQMS administration, Document Control, or a related area
- Experience within the pharmaceutical, biotechnology, medical device, or life sciences industry
- Strong hands-on experience administering and configuring an electronic Quality Management System
- Experience with ZenQMS or a comparable eQMS platform such as MasterControl, Veeva Quality, ComplianceQuest, TrackWise, or similar
- Strong understanding of regulated environments, including GMP/GCP/GLP
- Experience with system configuration, workflow design, change management, and software lifecycle management
- Experience supporting CSV, UAT, validation documentation, and system implementations
- Strong understanding of electronic document control processes
- Experience developing Quality Systems reporting, dashboards, metrics, and analytics
- Excellent written and verbal communication skills
- Strong project management and organizational abilities
- Ability to work independently and make sound decisions with minimal supervision
Preferred Qualifications
- Experience implementing or enhancing eQMS platforms
- Experience supporting an LMS or regulated training management system
- Experience with computer-based training tools such as Camtasia, Captivate, or similar
- Experience developing training materials and delivering instructor-led or electronic training
- Experience with process automation and workflow optimization
- Experience supporting regulatory inspections and inspection readiness
- Experience working with cross-functional Quality, IT, Validation, and business teams
- Experience managing projects from requirements gathering through implementation
- Strong understanding of Quality Systems metrics and continuous improvement methodologies
What We're Looking For
The strongest candidate will be a hands-on Quality Systems professional, not simply a project manager. You should be comfortable getting into the system, configuring workflows, troubleshooting issues, gathering requirements, supporting validation, and working directly with business stakeholders.
We're looking for someone who is:
- Hands-on and technically capable
- Strong with eQMS configuration and administration
- Comfortable working across Quality, IT, and business functions
- A strong communicator and collaborative team player
- Proactive and able to work independently
- Comfortable wearing multiple hats in a growing organization
- Experienced navigating ambiguity and changing priorities
- Focused on continuous improvement and process optimization
This is an excellent opportunity for someone who wants to have significant ownership over the Quality Systems environment and make a visible impact within a growing life sciences organization.
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