Job Description

Associate Director, IT Quality Engineering

Department: IT/Quality and Compliance?

Type of role: Contract or Contract to Hire


Location: Sunnyvale, CA

General Position Summary:

The Associate Director, IT Quality Engineering is responsible for developing and implementing Corporate strategy for ensuring Computerized systems, applications and Infrastructure used in support of Clinical, Laboratory, R&D, Commercial, Manufacturing, Engineering operations are validated and qualified following established policy and procedures in-line with Industry best practices and using a Risk based approach. The Associate Director Quality Engineering will provide guidance and oversight of processes related to cGMP such as IT Infrastructure Software and Hardware systems commissioning and Applications validation, Qualification and Validation, Computer System Configuration Management and Computer System Validation (CSV). With focus on local as well as regional and enterprise systems, the incumbent will ensure compliance with corporate policies and procedures including applicable regulatory guidelines.

Key Accountabilities / Core Job Responsibilities:
  • Lead and provide clear directions with design considerations for more complex validation and Qualification projects that may involve multiple technical teams
  • Lead and manage a team of Quality Engineering subject matter experts in authoring and revising SOP and Validation deliverables for both GXP and Non-GXP Systems and Applications.
  • Monitors resources and budget for Software Quality testing and validation activities.
  • Provide leadership and direction in the identification of risks and the development of mitigation strategies for Computer systems validation and qualification projects.
  • Manage project teams to provide assurance that requirements, design, and other project deliverables meet standards as appropriate.
  • Drives test execution and status reporting including testing automation tools (e.g. HP ALM) to reduce paper-based testing approaches.
  • Manages and monitors defect reports and works with developers and other project team members to verify resolution.
  • Oversee the deliverables of managed service provider of testing services
  • Provide testing strategies for GAMP hardware and software using a Risk based approach.
  • Consult on and provide strategies for performing Risk assessments
  • Oversee computer system validation and IT Infrastructure Qualification including Cloud based applications and Infrastructure platforms.
  • Provide oversight of the change control technical assessment/evaluation process and manage escalation of changes beyond site.
  • Align on change control requirements to manage the requested change in consultation with Quality Assurance.
  • Support regulatory inspections and audits (internal and external) of Computerized systems and IT Infrastructure.
  • Review and approve proposed changes to systems and procedures, as appropriate.
  • Review and approve protocols and summary reports.
  • Develop, collect, track, review and report metric information for use in continuous improvement of areas of responsibility.

Qualifications and Requirements:

Bachelor’s or master’s degree in technical discipline (Computer Science/Engineering or similar Life Sciences).
12+ years of relevant industry experience, including 5+ years in a leadership role with related experience in Quality Engineering with related experience such as Computer System Validation in an FDA regulated and GMP environment
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
Minimum 5 years of Team management/leadership experience, preferred.
Experience in the medical and/or pharmaceutical industry required.
Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
Proficiency in Computer System Validation in a GMP environment.
Experience with using Test Automation tools like HPALM, equipment and utility IQ/OQ/PQ/PV.
Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
Strong knowledge of GMP, GAMP, SOPs and quality systems.
Experience with internal and external audit principles.
Strong knowledge of change control and CAPA practices/strategies.

Application Instructions

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