Quality Engineer Manager
About The Position
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.
Requirements
- 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
- 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.
Nice To Haves
- CQE preferred.
- 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.
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.
Benefits
- 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
- other company-sponsored programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
