Manager, Quality Systems

Parabilis Medicines•Cambridge, MA

5d•$125,000 - $155,000•Remote

About The Position

The Quality Systems Manager at Parabilis Medicines is responsible for implementing and maintaining the company’s quality management system (QMS) to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH, etc.) and internal standards. The role sits at the center of compliance, operations and continuous improvement and is a vital partner for all GxP functions in the organization.

Requirements

Bachelor’s degree in life sciences or equivalent
6+ years of industry experience with hands-on quality systems work and knowledge of regulatory requirements across various compliance categories (GMP, GCP, etc.).
Proficient in Veeva electronic Quality Management System including documentation, quality events and training.
Skilled in data integrity principles.
Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus

Responsibilities

Manage Core Quality Management System (QMS) Elements
Document Control: Manage the lifecycle of GxP documents to ensure compliance with regulations and internal procedures. This includes but is not limited to formatting, routing workflows, managing metadata, reviewing, approving and making documents effective.
Quality Events: Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations.
Inspection Readiness: Support all inspection readiness initiatives including but not limited to self-inspections and regulatory inspections.
Management Review: Support the tracking and reporting of quality KPIs (e.g., deviation closure time, audit findings, etc.) and assist in the preparation of slides, meeting coordination and presentation of quality trends to senior leadership.
Supplier Management: Support qualification and approval activities of external suppliers.
Training Administration: Manage training requirements, curricula and learner roles in the company Learning Management System (LMS). Collaborate with process owners to ensure that procedures and other training material are assigned appropriately. Provide training metrics to assist in on time training completion.