Quality Engineer Manager

Forma Life Sciences•Irvine, CA

29d•Hybrid

About The Position

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. 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. 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.

Requirements

B.S. Degree in Engineering or Science
8-10 years of industry experience
knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and / or Six-Sigma
CQE preferred.
Technical skills
Risk Management
Computer System Validation
Cleaning validation and equipment qualification experience
Proficient in Change control process
Working independently to pull and trend data and write reports.

Nice To Haves

Must be collaborative and work in a fast passed CRDMO environment.
Ability to work with clients and also support client/health authority audits by representing QA.
Advice other teams on QE activities and utilize project management skills for biannual and annual activities.

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.