Job Title: Quality Engineer Manager

Department: Quality & Compliance

Reporting To: Head of Quality

Classification: Exempt

Compensation Range: $110,000-$160,000

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.

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.