Director, Quality Engineering (Remote)
Director, Quality Engineering
Quality – San Carlos, California
The Director, Quality Engineering will lead the Quality efforts to support the development of a commercial scale cGMP cell therapy manufacturing facility. This Director, Quality Engineering will be responsible for supporting the design, installation and evaluation of equipment, utilities, components, products and systems while ensuring they are fully operational, effective and free from defects. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools.
- Developing and implementing quality management systems in manufacturing industries.
- Analyzing, identifying and implementing manufacturing and/or business process improvements which will improve capability and performance.
- Creating and maintaining company documentation, such as quality manuals, and quality procedures.
- Troubleshooting problems or flaws in the item provided for testing.
- Meeting with members of the production team to offer recommendations and share results.
- Maintaining and controlling calibration records for all test and inspection equipment.
- Applying good manufacturing practice and observing that it is being adhered to.
- Performing tests and measurements using existing measurement equipment.
- Participating in teams to help make necessary improvements and changes to all process related issues in the production department.
- Establish and track quality metrics for engineering and processes and present improvement opportunities at Management Review meetings.
- Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
- Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at commercial facility.
- Prepare quality metrics; analyze data relating to equipment, systems, qualifications, validations; coordinate the necessary quality adjustments.
- Education and Qualifications
- BA/BS degree in scientific or engineering discipline
- 15+ years of biopharmaceutical industry experience
- Demonstrable experience creating and utilizing inspection/testing systems.
- Demonstrable experience managing teams of both internal and contracted personnel
- Strong experience developing and executing protocols for single-use process systems in a CGMP environment
- Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
- Demonstrable experience utilizing risk-based assessments as outlined in ASTM E2500 and setting up lifecycle verification programs for manufacturing systems.
- Ability to effectively communicate with management and project team members
- Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
- Strong professional 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 with minimal direction and changing priorities
- Experience identifying changes, driving improvements and streamlining processes required
- Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project