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Oversees daily Quality Engineering functions to ensure compliance with cGMP regulations and internal quality standards. Leads investigations for deviations and CAPAs while providing quality oversight for validation protocols and technology transfers.
Requires a B.S. degree in Engineering or Science and 8-10 years of industry experience with knowledge of FDA and GMP regulations. Proficiency in risk management, computer system validation, and cleaning validation is essential.
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
Required Qualifications
Preferred Qualifications
Compensation & Benefits
The expected base salary range for this exempt position is $110,000 to $160,000 per year, based on experience, skills, qualifications, internal equity, and business needs. Final title and compensation will be determined based on the candidate’s experience level, technical accounting depth, leadership capability, and overall alignment with the role.
Forma offers a comprehensive and competitive benefits package designed to support employee health, well-being, financial security, and overall quality of life. 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, 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 requirements.
Work Environment & Physical Requirements
This role is primarily performed in an office environment at Forma’s Irvine facility, with onsite presence required based on business needs. The employee is regularly required to use a computer, communicate with others, review financial data, and attend meetings. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
Equal Employment Opportunity & Reasonable Accommodation
Forma Life Sciences is an Equal Opportunity Employer. We consider qualified applicants for employment 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 federal, state, or local law.
Forma provides reasonable accommodations to qualified individuals with disabilities and sincerely held religious beliefs, practices, or observances, as required by law. Applicants or employees who need accommodation to participate in the hiring process or perform essential job functions should contact Human Resources.
Agency/Search Firm Notice
Forma Life Sciences does not accept unsolicited resumes from agencies or search firms for this position unless a valid written agreement is in place. Any unsolicited resumes submitted to Forma or its employees will be considered property of Forma, and no fee will be paid if the candidate is hired as a result of an unsolicited referral.
Additional Information
Where molecules become medicine
Forma is where molecules become medicine. Formed in 2026 as a next-generation CDMO, we offer formulation development and manufacturing for oral solid dosage programs from early clinical development through commercial manufacturing. Our capabilities are grounded in nearly 30 years of formulation expertise, including deep experience in amorphous solid dispersion and modified release technologies, developed through long-standing operations in Southern California.
Offices: 9601 Jeronimo Rd, Irvine, California 92618, US · 72 Fairbanks, Irvine, California 92618, US
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