Sr. Manager, Quality Systems
Location: Emeryville, CA
Department: R&D Quality
Quality is our primary guiding principle at Zogenix. It is the foundation on which all functions and activities are performed. Excellence in the management of Quality is fundamental and the foremost aspect upon which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective development, operations and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases. The Quality function within the Pharmaceutical Operations (PharmOps) team is responsible for integrating, executing, and inspiring Quality throughout all functions at Zogenix.
The Senior Manager, Quality Systems, is responsible for the execution and management of Zogenix quality systems policies and procedures to support regulated activities. The role will support the day to day management and oversight of the Zogenix Quality Management System and in particular completion of quality activities related to the QMS (e.g. complaint and investigation handling). The Senior Manager, Quality Systems will be required to act as a Subject Matter Expert during regulatory inspections for the QMS as well as to partner with all Zogenix departments at all levels.
The Senior Manager, Quality Systems is responsible for the execution of the quality strategy as it pertains to the Zogenix QMS:
- Manage and maintain the Zogenix QMS in a compliant and timely manner.
- Receive, evaluate, and investigate product and distribution complaints
- Lead quality evaluation and approval of change controls and participate in Change Control Committee
- Author and review SOPs
- Evaluate and approve quality deviations and manage CAPA
- Perform internal audits as needed
- Support supplier qualification activities, including performance assessment reports, risk assessments and audits as required
- Collect data for Management Review
- Conduct QMS training courses such as change control, CAPA owner, GMP
- Monitor and escalate to push for on-time completion of QMS activities.
- Support regulatory inspections and readiness programs and act as SME in the absence of the QMS lead
- Support the ongoing development of our training program
- Other duties as assigned.
- Bachelor’s Degree in a science or engineering related discipline is preferred
- 7+ years’ experience within the pharmaceutical industry under EU or US GxPs with at least 5 years’ experience in Quality
- Auditing (internal and vendor audit), complaint and deviation investigation and evaluation experience is required
- Auditor training required; lead auditor training desired
- Possesses a thorough knowledge of pharmaceutical Quality System Regulations, and other relevant regulations in US and EU
- A working knowledge of databases and spreadsheets, including Electronic Quality Management Systems (EDMS), is
- Self-motivated individual with the ability to think and work
- Must possess strong skills in leadership, communication, and project management.
- Solid management, organizational, technical writing, and planning skills are a
Special Working Conditions
- This position is based in the USA and will require some domestic and international travel. Regular travel to Emeryville office is expected for remote worker.