Manager, Quality Engineering

A clinical-stage biopharmaceutical organization is expanding their Quality Engineering team. Their pipeline includes both clinical and preclinical programs targeting conditions in the liver, lungs, and beyond, with a focus on diseases that are difficult to address using traditional small molecules or biologics.

The Manager, Quality Engineering will play a key leadership role within the Quality department, overseeing activities related to the commissioning, qualification, and validation (CQV) of equipment and facilities supporting GMP manufacturing and GLP/GMP testing. This position ensures quality oversight across the process development lifecycle, including validation and annual drug product reviews. The role is responsible for managing CQV-related Quality functions, developing and maintaining procedures, and ensuring compliance with current industry standards for clinical and commercial GMP operations.

Key Responsibilities

• Author, revise, and manage procedural documents (Policies, SOPs, Work Instructions, Forms, Protocols, Test Methods) using established templates.
• Collaborate cross-functionally with departments such as Manufacturing, Facility Engineering & Automation, Analytical Development, QC, BioA/DMPK, and Facilities to support equipment installation, maintenance, and validation.
• Partner with system owners and end users to define system requirements and intended use for validation.
• Review and approve internal and vendor documentation, including validation master plans, qualification protocols, user requirements, system impact assessments, and final reports.
• Manage document workflows in the organization's electronic document management system (EDMS), including Veeva QualityDocs.
• Initiate, review, and approve change controls related to equipment and facility systems within the EDMS/QMS.
• Maintain equipment and instrument data in tracking systems.
• Support the metrology program, including calibration planning, procedure development, vendor coordination, and data review.
• Oversee cleaning verification and validation activities for facilities and equipment.
• Participate in deviation and CAPA investigations related to CQV and metrology.
• Develop and implement plans for periodic re-qualification of instruments, equipment, and facilities.

Key Qualifications

• Bachelor's degree in a relevant scientific discipline. Advanced degree in a scientific or engineering field would be highly desirable.

• Minimum of 8 years of experience in the pharmaceutical, biotech, contract manufacturing, or contract research industry, with a focus on equipment/instrument qualification.
• At least 3 years of experience in a commercial GMP manufacturing environment with hands-on CQV execution.
• Strong understanding of GMP and/or GLP regulatory requirements.
• Experience with electronic document management systems in regulated environments would be a plus.

• Quality certifications such as CQA (Certified Quality Auditor) or CQMP (Certified Quality Management Professional) is highly desirable.