Quality Engineer Manager

Job Title:

Quality Engineer Manager

Department:

Quality & Compliance

Reporting To:

Head of Quality

Classification:

Exempt

Compensation Range:

$110,000-$160,000

What We Do

Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of Irvine operations from BioDuro and is operating as a newly established, independent entity. As a result, Forma’s standalone online presence is still being built.

Why Forma?

Unlike large, highly layered organizations, Forma operates with a hands-on, execution-driven model. Our teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results.

Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients, and contribute to building scalable systems and processes as the company grows. This is an environment well suited to individuals who value autonomy, technical excellence, and the opportunity to help shape a growing organization.

Job Overview/Summary

The Quality Engineer Manager oversees the daily activities for Quality Engineering functions. This role ensures cGMP regulations and internal quality standards while supporting both development and commercial programs. The position works cross-functionally with teams to lead investigations for deviations, OOS/OOT, CAPAs, provide QA support for review of IQ/OQ and PQ protocols and reports for process validation, equipment qualification, and technology transfers. The Quality Engineer Manager also assists with audits, regulatory inspections, and continuous improvement initiatives to ensure product quality and regulatory compliance throughout the manufacturing lifecycle.

Essential Functions and Responsibilities

• Oversee the Environmental Monitoring and Cleaning Validation program.
• Provide quality oversight for all process, equipment and instrument validation and/or verification protocols and reports.
• Work closely with cross-functional stakeholders to ensure quality oversight for Computer Systems Validation of all software systems facility wide (i.e., Ignition, Empower. NetSuite).
• Trend CPP and CQA parameters to identify trends and work with operations to identify corrective actions as appropriate.
• Oversee Risk Management program and conduct risk assessments and impact assessments for change controls as needed.
• Serve as Subject Matter Expert within business on regulatory and compliance requirements for all areas of responsibility.
• Oversee review and release of batch records.
• This job description is

  is subject to change at any time.