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Associate Director, Quality Engineering - Data Analysis

Santa Monica, CA, USA | Gilead Sciences

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Operations / Production
    Consulting - IT
  • Experience:
    10-12 years
Job Description:
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Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!


We are seeking a highly motivated individual to join our Quality Engineering team as Associate Director, Quality Engineering.This position will be located at the Kite headquarters in Santa Monica, CA and perform as leader in Kite’s Quality Engineering department. Reporting to Kite’s Head of Quality Engineering you’ll interface and build strong partnerships with Quality, IT, Validation, Engineering, Manufacturing, R&D and other parts of Kite’s organization.


Responsibilities (include, but are not limited to):


Develop and implement innovation based metrics for Quality in Kite’s Technical Operations organization.

Provide oversight to implementation of automated interfaces to IT systems containing metrics source data.

Collaborate with Process Development and Manufacturing in a Community of Practice around metrics, statistics and visualization of quantitative data in support of Quality Management Review and ad hoc data analytics.

Manage a high performing team of talented Quality Engineers.

Lead the Data Analysis function for Quality Engineering.

Build and lead cross functional Community of Practice for metrics, statistics and big data management.

Continuously provide and refine quality metrics to management for review.

Support Kite’s Quality Management Review at individual sites as well as global functions.

Support Kite’s QRM Community of Practice as key member.

Develop metrics for Validation, Risk Management, System Configuration Management and Data Integrity.

Lead implementation of Kite’s Data Analytics Platform (IT application).

Co-Chair and provide guidance to Kite’s Process Monitoring Review Board.

Partner with QE’s Quality Risk Management team in development of a central Quality Risk Register.

Support regulatory inspections and audits.

Support vendor qualification and – compliance management.

Track, review and report metric information for use in continuous improvement.

Ability to travel internationally.

Perform other duties as required.

Qualifications:


BS or BA degree in technical discipline (Mathematics/Computer Science/Engineering or similar) and 10+ years of data analytics experience in a GMP environment (Drug Substance or Drug Product)


OR


MS degree in technical discipline (Mathematics/Computer Science/Engineering or similar) and 8+ years of data analytics experience in a GMP environment (Drug Substance or Drug Product)


Minimum of 8 years of management experience.

Working knowledge of regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).

Proficiency in statistical evaluation along the pharmaceutical product life cycle.

Proficiency in application and use of advanced statistics and – data analytics.

Operational experience in statistical process control.

Quality Assurance, GMPs, global Health Authority Regulations and Validation practices/principles.

Experience with internal and external audit principals.

Experience in the medical and/or pharmaceutical industry.ASQ, Black Belt/Green Belt certifications, preferred

Proficient in MS Word, Excel, Power Point and statistical applications.

Strong written and verbal communication skills.

Ability to communicate and work independently with scientific/technical personnel


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