Key Responsibilities
Assist in Quality oversight for external GMP production and testing activities for clinical stage products and materials
Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Perform review of Regulatory submissions and source data verification
Manage review and approval of analytical testing protocols, methods, and qualification/validation reports
Support review of regulatory filing activities as needed
Assist in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
Support SMEs in managing documents through the review, approval, and release workflow in the eQMS (e.g., Veeva Vault)
Serve as a resource and coach for SMEs navigating quality processes and eQMS workflows
Identify and escalate quality issues or systemic trends to Quality management
Support audit readiness by ensuring quality records are complete, accurate, and on-time
Contribute to continuous improvement initiatives within the Quality Systems function
Other duties as assigned
Quals--
We are seeking an experienced Quality Operations Engineer contractor to support our GMP biotechnology operations. In this role, you will serve as a hands-on quality partner to Subject Matter Experts (SMEs) across manufacturing, laboratory, and technical functions. Your primary focus will be facilitating the timely and compliant completion of quality records including change controls, deviations, laboratory investigations, and controlled document revisions within our electronic Quality Management System (eQMS). This role will assist with the continued quality oversight of GMP production and testing of clinical trial materials at contract development and manufacturing organizations (CDMOs) and contract testing labs (CTLs). In addition, responsible for review of Regulatory submissions and source data verification. The individual will be a collaborative, quality professional with biotech GMP compliance experience, with exceptional communication skills to support a pipeline of gene editing products. This role will be responsible for document review as well as assisting with the maintenance of phase-appropriate quality systems, including GxP compliance, document control, validation, and quality control. This role is based at Verve s Boston headquarters
The ideal candidate brings strong working knowledge of GMP regulations, excellent writing and communication skills, and the ability to guide non-quality personnel through complex quality processes efficiently and without unnecessary burden.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.