GMP Quality Manager
Posted on Mar 12, 2019 by OlonRicerca Bioscience
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.
MAJOR ACTIVITIES AND RESPONSIBILITIES
- 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
- 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.