Quality Assurance Specialist
One DNA Way South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
Position: Quality Systems and Business Processes
The purpose of this position in Quality Systems and Business Processes is to support the global External Quality Development (IMP) organization in providing Quality oversight to Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs) and Partners, as well as internal stakeholders.
This position will be based in South San Francisco and reports to the Head of Quality Systems and Business Processes, External Quality Development (IMP).
Level: N/A, Contractor
- Actively contribute to the development and implementation of Standard Operating Process/Procedures, Tools and Templates in External Quality Development (IMP).
- Lead or participate in department and cross-functional continuous improvement projects and drive implementation of best practices.
- Support the authoring and revisions of Standard Operating Procedures and guidance documents.
- Lead or participate in Quality initiatives, as assigned.
- Identify and participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relations.
- Work globally with other Genentech/Roche groups to harmonize and understand Quality Systems and Business Processes.
- Prepare routine reports and trend analysis of Quality Ops Metrics.
- Nurture and champion a continuous improvement mindset.
- BA/BS in Life Sciences or equivalent.
- At least 12 years of experience in Quality Assurance, Quality Control, Manufacturing in the biotechnology or pharmaceutical industry.
- Strong knowledge of cGMPs, and regulations applicable to U.S. and international Regulatory agencies.
- Demonstrate excellent problem solving skills using critical thinking and identifying appropriate solutions.
- Excellent verbal and technical written communication skills.
- Strong interpersonal skills, and negotiation skills are essential.
- Familiarity with computer systems and ability to quickly become familiar with new software (e.g. Trackwise, SAP).
- Leads project team members to effectively execute local and cross-functional projects.
- Demonstrated experience in working effectively with local and global teams.
- Greenbelt certification or knowledge of LEAN/Six Sigma desired.