Manager, Quality Systems Temporary
San Carlos, CA 94070
Manager, Quality Systems Temporary (contract to 12/31/19)
San Carlos, California
The Manager, Quality Systems Temporary will be responsible for the improvement, design, development, implementation and maintenance of the GxP Quality Management System (QMS) processes. This includes, but is not limited to, Change Control, Deviation and other Non-Conformances, CAPA, Supplier Management, and Risk Management. This position will address gaps associated with the current Quality System processes as part of preparations for current Phase 2, Phase 3 and future clinical and commercial operations.
- Support the development, continuous improvement and implementation of Quality Systems (Deviation, CAPA, Change Control, Complaint, Risk Assessment); paper based and electronic solutions
- Track quality metrics for QMS processes analyze data and coordinate necessary quality adjustments.
- Support the implementation of risk management-based approaches.
- Represent Quality on cross-functional teams to complete projects, address quality issues and identify quality system improvements.
- Develop or review, Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements.
- Assist in maintaining internal quality systems and policies throughout the company.
- Assist in additional quality operations functions as needed.
Education and Qualifications
- BA/BS degree (scientific or engineering discipline preferred).
- Five or more years of Pharma/BioTech industry experience in Quality
- Direct experience with key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, and Management Review); electronic systems experience preferred
- Strong interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders.
- Ability to meet deadlines and multi-task efficiently.
- Must be comfortable in a fast-paced environment and changing priorities.
- Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project.