Description
A biopharmaceutical company located in the San Francisco Bay Area is currently seeking a Manager, GMP Quality reporting to the Associate Director of GMP Quality.Essential duties and responsibilities include but are not limited to the following:
Assist with GMP vendor management program, including, but not limited to the following:
- Audit scheduling, agenda and report
- Follow-up with vendor on response and commitments to ensure timely closure
- Vendor KPI
- Conduct investigations with guidance from management on GMP issues
- Assume lead role in investigating potential manufacturing / process issues with a goal of identifying potential root cause and assessing potential product and process quality impact
- Investigate, monitor, and follow up on CAPAs for completion and effectiveness
- Author and update management of investigational findings
- Communicate status of quality investigation, recommended course of action, and the need for additional medical and/or supplementary information relevant to investigations
- Communicate the status of product quality analysis and seek additional information relevant to conclude the investigation
- Perform risk analysis activities including FMEA.
- Work cross-functionally with various groups that have opportunity to impact the investigation outcome (Clinical Operations, Clinical Quality Assurance and Compliance, Pharmaceutical Operations, etc.)
- Monitor investigations, CAPA, Change Controls, and provide trending and metrics quarterly for inclusion in management review and annual product quality review
- Develop and revise Standard Operating Procedures and forms as needed
- Assist with maintenance of the stability program as requested
Requirements:
- Experience working with small molecules (CDER)
- Extensive working knowledge of GMP regulations and experience working with CMO
- Able to interact, cooperate, and motivate across departments and functions
- Some travel may be required
- Prior experience trend analysis, with root cause investigation tools and complaint file documentation
- Strong working Knowledge of US and Ex-US regulations
- Knowledge of MasterControl Incident and CAPA Reporting system
- PC knowledge to include MS Word, Excel, PowerPoint, Access & Visio, Data trending tools (Jmp, Minitab) and database management
Education:
- Bachelors in science related field.
- Minimum 8 years of process engineering, quality engineering
To find out more about Real please visit www.realstaffing.com