{"schemaVersion":"jobsearcher.job.v1","id":"ea29f4883de25eb0f490ebc8","url":"https://jobsearcher.com/jobs/ea29f4883de25eb0f490ebc8","canonicalUrl":"https://jobsearcher.com/jobs/ea29f4883de25eb0f490ebc8","title":"Quality Engineer Manager","description":"What We Do\nForma 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.\n\nJob Title: Quality Engineer Manager\n\nDepartment: Quality & Compliance\n\nReporting To: Head of Quality\n\nClassification: Exempt\n\nCompensation Range: $110,000-$160,000\n\nWhy Forma?\nUnlike 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.\n\nEmployees 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.\n\nJob Overview / Summary\nThe 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.\n\nEssential Functions And Responsibilities\n\nOversee the Environmental Monitoring and Cleaning Validation program\n\nProvide quality oversight for all process, equipment and instrument validation and/or verification protocols and reports.\n\nWork closely with cross‑functional stakeholders to ensure quality oversight for Computer Systems Validation of all software systems facility wide (i.e., Ignition, Empower, NetSuite).\n\nTrend CPP and CQA parameters to identify trends and work with operations to identify corrective actions as appropriate.\n\nOversee Risk Management program and conduct risk assessments and impact assessments for change controls as needed.\n\nServe as Subject Matter Expert within business on regulatory and compliance requirements for all areas of responsibility.\n\nOversee review and release of batch records.\n\nRequirements\nRequired Qualifications\n\nB.S. Degree in Engineering or Science\n\n8‑10 years of industry experience\n\nKnowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and/or Six‑Sigma\n\nTechnical skills:\n\nRisk Management\n\nComputer System Validation\n\nCleaning validation and equipment qualification experience\n\nProficient in change control process\n\nWorking independently to pull and trend data and write reports\n\nPhysical Demands: lift 20 pounds, walk across plant/warehouse, driving to and from 2 sites\n\nPreferred Qualifications\n\nMust be collaborative and work in a fast‑paced CRDMO environment\n\nAbility to work with clients and also support client/health authority audits by representing QA\n\nAdvice other teams on QE activities and utilize project management skills for biannual and annual activities.\n\nBenefits\nCompensation & Benefits\nThe 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.\n\nForma 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.\n\nWork Environment & Physical Requirements\nThis 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.\n\nEqual Employment Opportunity & Reasonable Accommodation\nForma 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.\n\nForma 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.\n\nAgency/Search Firm Notice\nForma 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.\n\nAdditional Information\n\nThis 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.\n\nForma Life Sciences may modify job duties or responsibilities at any time, with or without notice, consistent with applicable law.\n\nEmployment is at‑will unless otherwise provided in a written agreement signed by an authorized company representative.\n\n#J-18808-Ljbffr","company":"Forma","rawCompany":"forma","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:33:35.420Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer Manager","description":"What We Do\nForma 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.\n\nJob Title: Quality Engineer Manager\n\nDepartment: Quality & Compliance\n\nReporting To: Head of Quality\n\nClassification: Exempt\n\nCompensation Range: $110,000-$160,000\n\nWhy Forma?\nUnlike 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.\n\nEmployees 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.\n\nJob Overview / Summary\nThe 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.\n\nEssential Functions And Responsibilities\n\nOversee the Environmental Monitoring and Cleaning Validation program\n\nProvide quality oversight for all process, equipment and instrument validation and/or verification protocols and reports.\n\nWork closely with cross‑functional stakeholders to ensure quality oversight for Computer Systems Validation of all software systems facility wide (i.e., Ignition, Empower, NetSuite).\n\nTrend CPP and CQA parameters to identify trends and work with operations to identify corrective actions as appropriate.\n\nOversee Risk Management program and conduct risk assessments and impact assessments for change controls as needed.\n\nServe as Subject Matter Expert within business on regulatory and compliance requirements for all areas of responsibility.\n\nOversee review and release of batch records.\n\nRequirements\nRequired Qualifications\n\nB.S. Degree in Engineering or Science\n\n8‑10 years of industry experience\n\nKnowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and/or Six‑Sigma\n\nTechnical skills:\n\nRisk Management\n\nComputer System Validation\n\nCleaning validation and equipment qualification experience\n\nProficient in change control process\n\nWorking independently to pull and trend data and write reports\n\nPhysical Demands: lift 20 pounds, walk across plant/warehouse, driving to and from 2 sites\n\nPreferred Qualifications\n\nMust be collaborative and work in a fast‑paced CRDMO environment\n\nAbility to work with clients and also support client/health authority audits by representing QA\n\nAdvice other teams on QE activities and utilize project management skills for biannual and annual activities.\n\nBenefits\nCompensation & Benefits\nThe 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.\n\nForma 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.\n\nWork Environment & Physical Requirements\nThis 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.\n\nEqual Employment Opportunity & Reasonable Accommodation\nForma 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.\n\nForma 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.\n\nAgency/Search Firm Notice\nForma 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.\n\nAdditional Information\n\nThis 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.\n\nForma Life Sciences may modify job duties or responsibilities at any time, with or without notice, consistent with applicable law.\n\nEmployment is at‑will unless otherwise provided in a written agreement signed by an authorized company representative.\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:33:35.420Z","dateModified":"2026-07-16T03:33:35.420Z","hiringOrganization":{"@type":"Organization","name":"Forma","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ea29f4883de25eb0f490ebc8"},"url":"https://jobsearcher.com/jobs/ea29f4883de25eb0f490ebc8"}}