Principal Specialist, Quality Operations

Role: Senior quality assurance professional providing technical leadership within GxP operations, supporting manufacturing, quality control, and quality systems. Responsibilities: lead complex investigations, review quality documentation, assess risks, and drive continuous improvement initiatives; serve as a subject matter expert on quality strategies and compliance; represent Quality during audits and inspections; contribute to quality system enhancements and operational risk mitigation. Requirements: B.S. in science, engineering, or technical field; 12+ years in cGMP pharma or combination product manufacturing (Master’s preferred); strong technical writing, investigation, and change control experience; demonstrated cross-functional influence and technical mentorship; ability to work independently in a fast-paced environment. Preferred Qualifications: familiarity with combination products and device regulations, experience with regulatory inspections, quality metrics development, and certifications such as ASQ CQE or Lean Six Sigma Black Belt. HighValue: extensive GxP experience, combination product knowledge, regulatory inspection support, quality system development, and cross-functional collaboration. WorkSetup: not specified; occasional travel likely.