Quality Assurance Manager

We are seeking a Quality Assurance Systems Manager to support the development, maintenance, and continuous improvement of a pharmaceutical Quality Management System (QMS). This role ensures compliance with FDA regulations and internal quality standards while driving operational excellence across quality systems. The ideal candidate will have strong experience in GMP environments, quality systems oversight, and regulatory compliance within pharmaceutical manufacturing operations. Quality Assurance Systems Manager $85,000 – $95,000 annually Key Responsibilities Maintain and oversee the site Quality Management System (QMS) in compliance with FDA 21 CFR Parts 210 and 211 and applicable regulatory requirements Manage core quality systems including: Change Control, Deviations and Non-Conformance Investigations, CAPA (Corrective and Preventive Actions), document Control and SOP lifecycle management Quality complaints handling Ensure timely and compliant review of batch records, quality records, and associated documentation Support FDA inspections, internal audits, and third-party regulatory audits Track, trend, and report quality system performance metrics to management Drive continuous improvement initiatives across quality systems and manufacturing support functions Support supplier quality oversight and qualification activities Ensure compliance with data integrity and electronic record requirements (21 CFR Part 11) Collaborate with Manufacturing, Quality Control, Regulatory Affairs, and Operations teams Support training programs to ensure GMP compliance and adherence to quality procedures Participate in validation activities related to processes, equipment, and systems Required Qualifications Bachelor’s degree in Chemistry, Biology, Pharmacy, or related scientific field (or equivalent experience) 5–7+ years of experience in pharmaceutical or FDA-regulated manufacturing environments Strong experience with GMP quality systems (CAPA, Change Control, Deviations, Document Control) Experience supporting FDA inspections and regulatory audits Familiarity with electronic Quality Management Systems (eQMS) such as MasterControl, TrackWise, or Veeva Vault Supervisory or team leadership experience in a quality environment Experience with validation activities (equipment, process, or cleaning validation) Strong understanding of data integrity and 21 CFR Part 11 compliance Experience working cross-functionally in manufacturing and quality operations #J-18808-Ljbffr