Quality Assurance Engineering Manager

Summary

The Quality Engineering Manager is directly responsible for creating, updating, and maintaining quality system documents. They will be expected to review, approve, and implement changes to quality system documents and records produced by document control, production, product development, and incoming inspection.

The position reports directly to the CEO/President.

Accountable for providing strategic leadership and operational ownership of the Quality Management System (QMS), ensuring regulatory compliance, process effectiveness, continuous improvement, and cross‑functional quality support throughout the product lifecycle. Responsible for establishing functional objectives, developing personnel, managing quality performance, and driving scalable quality systems that support company growth.

Accountable for implementing and sustaining the Prospect Life Sciences Operating System (OS) within the Quality organization by developing associates, driving organizational accountability, supporting strategic initiatives, monitoring key performance indicators, and ensuring Quality objectives are aligned with company Vision, Traction, and organizational goals.

Accountable for providing Quality Engineering leadership for assigned client programs by ensuring manufacturing processes, validation activities, quality deliverables, regulatory compliance, project schedules, budgets, and client expectations are successfully achieved while fostering long‑term client relationships and continuous process improvement.

• Responsible for owning and leading the Quality System core processes, including vision, objectives, compliance, best management practices, and adherence to the QMS.
• Responsible for ensuring all Quality associates have performance and development plans that support continuous improvement and functional excellence.
• Responsible for maintaining and continuously improving Quality System processes through internal and external audits and ongoing compliance activities.
• Responsible for ensuring the Quality functional group provides effective cross‑functional support through compliance guidance, quality oversight, risk management, design controls, and manufacturing readiness.
• Responsible for improving Quality System efficiency and scalability through the implementation of best practices, new tools, and AI‑enabled automation.
• Acting QSMR responsible for leading management reviews and audits with external parties including clients, registrar, and FDA inspections as applicable.

• Responsible for maintaining and completing my PEEP reviews on a quarterly basis.
• Responsible for attending, actively participating in, and providing content for NPI Manufacturing Transfer and Quality Operating System (OS) meetings.
• Responsible for reporting, tracking, and contributing to Manufacturing Transfer and Quality KPIs on a weekly basis, including accurate time tracking.
• Responsible for evaluating, developing, and coaching my direct reports to ensure role alignment, performance effectiveness, and readiness.
• Responsible for actively implementing EOS across all six components and supporting cross‑functional understanding and adoption of the system.
• Responsible for reinforcing organizational values through role modeling, coaching, and accountability.
• Responsible for collaborating with the CEO, Head of Product Development, and Operations to update, maintain, and execute against the company VTO.
• Actively pursue self‑initiated professional development opportunities beyond PLS-sponsored programs to enhance leadership, technical capability, and organizational impact.

• Responsible for delivering assigned client projects on time, within budget, and in compliance with regulatory and contractual requirements.
• Responsible for completing EOM/PRs and ensuring accurate invoicing for my projects by the first business day of each month.
• Responsible…