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GMP Quality Manager

Posted on Mar 19, 2019 by OlonRicerca Bioscience

Ohio, OH
Research & Development
Immediate Start
Annual Salary

GMP Quality Assurance (QA) Manager with in-depth experience in small molecule drug substance manufacturing. The GMP QA Manager will provide Quality oversight and support to the Technical Operations group for the manufacture and testing of non-clinical, clinical and commercial products. The GMP QA Manager will be accountable for driving Quality initiatives, maintaining/improving quality infrastructure and participating where needed on various CMC related project teams. The GMP QA Manager will be accountable for assuring compliance with Ricerca's Quality System, identifying/driving quality system improvement, quality oversight at the project level and generation of metrics to drive continuous improvement.

Key responsibilities while assuring the quality of materials manufactured and data generated.


  • Responsible for the review and approval of master batch records
  • Responsible for the review and approval of executed batch records and associated analytical data related to the manufacture of drug substances and drug products
  • Support the disposition of drug substances and drug products
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy and logic of root cause analysis, and impact to both quality and regulatory commitments.
  • Participate in supplier audits.
  • On-site monitoring of CMO manufacturing operations.
  • Oversight and reporting CMO performance metrics
  • Administer Quality Management System databases for change control, deviations, and CAPAs
  • Development, maintenance and training of GMP SOPs
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, etc.)
  • Data Integrity Compliance
  • Manage inspections by Regulatory Authorities

Specific Skills & Educational Qualification Educational Requirements

  • BS or equivalent in a technical discipline and a minimum of 7-10 years' experience of in the pharmaceutical/biotech industry
  • Must have at least 5 years' experience in Quality Assurance supporting manufacturing of small molecule drug substance for clinical and commercial use
  • Working knowledge and technical understanding of the manufacture and testing of drug substance and drug product
  • Working knowledge of cGMP principles with respect to FDA and EMA
  • regulations
  • Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
  • Experience in deviation investigations, determining root cause, and developing corrective action plans
  • Knowledge of drug development process
  • Experience is process justification, process validation, risk assessment, training and document management in addition to working in a contract environment considered a plus.

Olon Ricerca Bioscience LLC. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

Reference: 673351442