Manager, Quality Systems

About the role

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.

What you'll do

Responsibilities include, but are not limited to:

• 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.

Qualifications

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

Equal Employment Opportunity Statement

Zevra is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Notice to External Recruiters
Zevra does not accept unsolicited resumes from agencies or search firms. Recruiters are requested not to contact employees or hiring managers. All candidate submissions must be coordinated through our Human Resources team and require a prior written agreement. Any resumes sent without such an agreement will not create any implied obligation.

About Zevra Therapeutics, Inc.

We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies.

With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients.

Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients’ lives.