Associate Director, IT Quality Engineering
|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:
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.