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Sr. Director, Quality Systems and Compliance
2 months ago
Title: Sr Director Systems and Compliance
Location: South San Francisco, CA
Hybrid; 1 day a week remote
We are seeking an experienced professional to join our team as Director / Sr Director of Quality Systems and Compliance.
This candidate must be able to provide guidance to the Quality personnel and work cross-functionally with other departments. This person must be able to use paper-based and electronic quality systems.
Required skills
Strong knowledge of cGMP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards.
Responsible for implementation and ownership of the site Quality Systems program, processes, procedures, system administration and training.
- Define workflows for Change Control, CAPA, Deviation.
- Establish site Document Control and Management processes through Veeva QualityDocs including storage and archival.
- Establish site Training Program including curricula, metrics and monitoring.
- Responsible for setting, tracking, and trending of site Quality Metrics.
- Responsible for leading and facilitating Quality Management Review to drive quality improvements by leveraging detailed data review as well as identification of action items.
- Establish Quality Risk Management process and site Risk Register.
- Establish Complaints and Recalls program.
- Develop Site Master File by template and collaborate with cross functional partners to drive content.
- Responsible for implementation and ownership of the site Quality Compliance program, processes, procedures, system administration and training including:
- Establishment and successful implementation of the Supplier Quality Program with development and successful execution of the audit qualification and audit program.
- Internal audit program including evaluation of phase appropriate audit requirements.
- Development of site inspection readiness program and coordination of site regulatory strategy and inspection support.
Qualifications
- Minimum 15+ years of relevant industry experience, ideally in all clinical phases through commercialization and a degree in pertinent life sciences
- Experience in running front and back rooms for agency inspections and setting up Inspection readiness programs
- Independently motivated, detail oriented and good problem-solving ability
- Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members
- Proficient computer skills required with experience using Microsoft Word, Excel, and PowerPoint
- Veeva experience preferred
