Senior Manager, Quality Systems Zogenix, Inc.
THIS JOB HAS EXPIRED The Senior Manager of Quality Systems will manage Zogenix staff, contractors and outsource vendors in order to develop execute, manage and improve the Zogenix quality systems as an effective compliance tool for assuring the effectiveness and efficiency of quality processes.
This position provides quality and compliance leadership and participates in the design, establishment and maintenance of programs and processes that ensure quality products and systems are in compliance with current GMPs, GCPs, and GLPs for pharmaceutical, biotech and drug/device combination products.
REPORTS TO: Director of Quality
LOCATION: Emeryville, CA
SCOPE AND RESPONSIBILITIES:
The Senior Manager of Quality Systems is responsible for the implementation, improvement and oversight of the following Zogenix Quality Systems areas:
Product complaints including documenting, investigation, resolution, trending, and reporting.
Tracking and trending of Quality Issues (Deviations) and CAPA, including monitoring investigation progress through to closure. May also act as quality department lead on investigations as necessary.
Management of change control logs, tracking information, review boards and files. May also act as quality department lead on change project teams or review boards as necessary.
Participate in development and continuous improvement of policies and procedures for Zogenix quality system.
Periodic reporting on quality system status and leading or participating in quality system reviews.
Work with technical operations functions to develop and maintain product and design master files and history files for use in investigations, change control, and periodic product reviews.
Assist in hosting third party and regulatory inspections at Zogenix.
Manage schedule and performance of internal compliance audits, track audit CAPAs.
Possesses a thorough knowledge of cGMP's, cGCP's, QSR's, and other relevant regulations in US and EU. Solid management, organizational, technical writing, and planning skills are a must. A working knowledge of databases, including Electronic Document Management Systems (EDMS), Enterprise Resource Planning (ERP), and bill of material structures, is recommended.
Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership, communication, project management, and budget management.
Travel 10-20%, or as needed. Some overseas travel may be necessary.
BS/MS or equivalent in a relevant scientific discipline.
Requires a minimum of 7 years experience in Quality Systems/Quality Assurance, preferably in pharmaceuticals, biologics, medical devices, or bio-pharmaceuticals.
At least 3 years experience in management with experience managing contractors and vendors in an out-sourced environment.
||San Diego, CA |
THIS JOB HAS EXPIRED