Quality Engineer Manager

About Forma

Forma is a newly established contract development and manufacturing organization (CDMO) headquartered in Irvine, California. The business was created after acquiring the Irvine operations from BioDuro and is currently building its independent brand and online presence.

Forma follows a hands-on, execution-focused model rather than a heavily layered corporate structure. Teams work closely across functions to solve demanding technical and operational problems, act quickly, and deliver reliable quality outcomes. The environment suits people who enjoy ownership, technical rigor, and the chance to help shape a growing organization.

Role Overview

The Quality Engineer Manager leads day-to-day quality engineering activities. The role ensures compliance with cGMP requirements and internal quality standards while supporting both development and commercial programs. It involves cross-functional leadership on deviations, OOS/OOT investigations, CAPAs, and quality review of IQ/OQ/PQ protocols and reports for validation, qualification, and technology transfer work. The position also supports audits, regulatory inspections, and continuous improvement efforts to maintain product quality and compliance across the manufacturing lifecycle.

Key Responsibilities

• Manage the environmental monitoring and cleaning validation program.
• Provide quality oversight for process, equipment, and instrument validation or verification protocols and reports.
• Partner with cross-functional teams to ensure quality control over computer system validation for plant-wide software platforms such as Ignition, Empower, and NetSuite.
• Analyze CPP and CQA trends, identify patterns, and coordinate with operations on corrective actions where needed.
• Lead the risk management program and perform risk and impact assessments for change controls.
• Act as the internal subject matter expert for regulatory and compliance requirements across assigned areas.
• Review and approve batch records for release.
• Support investigations, deviations, out-of-specification and out-of-trend cases, CAPAs, audits, and regulatory inspections as required.
• Note that duties may change over time based on business needs.

Requirements

• Bachelor’s degree in Engineering or a scientific discipline.
• 8 to 10 years of industry experience.
• Working knowledge of FDA regulations and GMP, GLP, and GCP requirements.
• Exposure to Lean Manufacturing and/or Six Sigma methodologies.
• CQE certification is preferred.
• Strong background in risk management.
• Experience with computer system validation.
• Hands-on knowledge of cleaning validation and equipment qualification.
• Comfortable managing change control processes.
• Able to independently gather, trend, and analyze data and prepare reports.
• Physical requirements may include lifting up to 20 pounds, walking across plant or warehouse areas, and traveling between two sites.
• Must be collaborative and able to thrive in a fast-paced CRDMO environment.
• Ability to work with clients and support client or health authority audits in a QA representative role.
• Capable of advising other teams on quality engineering activities and using project management skills for recurring annual and semiannual tasks.

Compensation & Benefits

The expected annual base pay for this exempt role is between $110,000 and $160,000, depending on experience, skills, qualifications, internal equity, and business needs. Final title and compensation will be based on the candidate’s experience level, technical accounting depth, leadership ability, and overall fit for the position.

Benefits may include ACA-compliant medical, vision, and dental coverage; medical FSA and dependent care FSA options; generous paid time off; paid sick leave; company holidays; a 401(k) retirement plan; voluntary life insurance; disability insurance; critical illness, hospital, and accident insurance; legal and identity protection services; company-paid basic life and AD&D insurance; an aggressive bonus structure; monthly company events; and other company-sponsored programs, subject to plan terms and eligibility.

Work Environment

This role is primarily performed onsite at Forma’s Irvine facility, with in-office presence required according to business needs. The employee will routinely use a computer, communicate with others, review financial data, and attend meetings. Reasonable accommodations may be provided to qualified individuals with disabilities.

Equal Opportunity and Accommodation

Forma Life Sciences is an equal opportunity employer. Qualified applicants are considered without regard to race, color, religion, creed, sex, gender, gender identity or expression, sexual orientation, reproductive health decision-making, pregnancy, childbirth or related medical conditions, breastfeeding, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, citizenship status, protected hairstyle or hair texture, or any other status protected by applicable law.

Reasonable accommodations are available for qualified individuals with disabilities and sincerely held religious beliefs, practices, or observances as required by law. Candidates or employees who need accommodation during the hiring process or to perform essential job duties should contact Human Resources.

Agency Notice

Forma Life Sciences does not accept unsolicited resumes from agencies or search firms for this position unless a valid written agreement exists. Any unsolicited submissions will be treated as company property, and no fee will be paid if a candidate is hired from an unsolicited referral.

Additional Information

• This description is meant to outline the general nature and level of work involved and is not an exhaustive list of duties, responsibilities, or qualifications.
• Forma Life Sciences may update job duties or responsibilities at any time, with or without notice, as permitted by law.
• Employment is at-will unless stated otherwise in a written agreement signed by an authorized company representative.