Manager, Quality Systems

Zevra Therapeutics•Boston, MA

10d•Onsite

About The Position

The Manager, Quality Systems is a hands-on, execution-focused role responsible for owning the operational performance and continuous improvement of the company’s Quality Management System (QMS) within a lean Boston-based biotechnology environment. This position requires a strong systems thinker who balances strategic quality objectives with practical execution, ensuring that quality processes are efficient, inspection-ready, and scalable. The role maintains direct ownership across Document Management, Training Programs, and core QMS workflows, including Deviation Management, CAPA, Product Quality Complaints, Change Control, and Effectiveness Checks. The Manager is expected to actively drive workflow progression, remove operational bottlenecks, and partner cross-functionally to ensure timely and compliant execution of quality activities. Success in this role requires demonstrated experience operating within electronic quality systems, strong knowledge of FDA and EMA regulatory expectations, and the ability to work independently in a fast-paced, resource-conscious environment where hands-on contribution is essential. This is an on-site position located in the Boston, Massachusetts office.

Requirements

Bachelor’s degree in scientific, technical, or related discipline required.
5–10 years of experience in pharmaceutical or biotechnology GxP environments.
Hands-on experience administering electronic Quality Management Systems (e.g., Veeva, TrackWise, MasterControl, ZenQMS, or similar).
Demonstrated experience balancing document control, training administration, and quality workflow ownership.
Strong working knowledge of FDA and EMA regulatory expectations and inspection readiness practices.

Nice To Haves

Experience operating effectively within lean or growth-stage organizations preferred.
Experience developing training content and effectiveness assessments preferred.

Responsibilities

Serve as the primary owner of document lifecycle management including workflow design, routing efficiency, and controlled document governance.
Design and maintain pragmatic document structures and templates that support usability while maintaining compliance.
Develop and administer GxP training programs including role-based curricula, on-demand online learning, instructor-led sessions, and training effectiveness evaluations.
Partner with functional leaders to ensure training programs align with operational needs and regulatory expectations.
Own day-to-day execution and operational effectiveness of the electronic Quality Management System (eQMS).
Drive timely progression and closure of digital quality workflows including Deviations, CAPA, Product Quality Complaints, Change Control, Training, and Effectiveness Checks.
Identify process inefficiencies and implement practical continuous improvement solutions within the QMS.
Support configuration, implementation, and risk-based validation of digital quality systems.
Maintain compliance with global regulatory expectations including FDA and EMA requirements, data integrity principles (ALCOA/ALCOA+), 21 CFR Part 11, and EU Annex 11.
Generate meaningful metrics and dashboards that enable data-driven quality decisions.
Actively support inspection readiness activities and serve as a knowledgeable contributor during audits and regulatory inspections.
Provide responsive, customer-focused support across all organizational levels.
Lead by example through strong ownership, accountability, and proactive problem-solving.
Other responsibilities and tasks as assigned by the incumbent’s supervisor.