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 subject to change at any time.

Requirements

Required Qualifications

• 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.
• Physical Demands
• e.g. lift 20 pounds, walk across plant/warehouse, driving to and from 2 sites.

Preferred Qualifications

• 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.

Benefits

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

• This job description is intended to describe the general nature and level of work performed. It is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the position.

• Forma Life Sciences may modify job duties or responsibilities at any time, with or without notice, consistent with applicable law.

• Employment is at-will unless otherwise provided in a written agreement signed by an authorized company representative.