GMP Quality Manager

Chemicals, Inspection & testing labs
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
OlonRicerca Bioscience
Job Ref:

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.

Closing Date:
Contact Details:
OlonRicerca Bioscience
Contact: Bernadette Armbruster

You may return to your current search results by clicking here.

Latest Job Listings