Gilead Sciences, Inc. Director, Quality Engineering in Amsterdam, Netherlands

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

As the Director Quality Engineering you are developing the validation master plan for all processes and methods related to our lead product and follow on products. In this role you will report to the EU Site Head Quality of Kite Pharma.

About Kite Pharma

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours. Kite Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases, and cardiovascular conditions

Responsibilities:

  • Develop validation master plans based on cGMP/ISPE guidance for all processes and methods related to our lead product and follow on products.

  • Further develop, implement, and continuously improve the qualification and validation program requirements

  • Oversee computer system validation for Kite in Europe.

  • Build and manage team of Quality Engineering subject matter experts.

  • Manage the change control process for validated computerized systems.

  • Ensure alignment of automation system qualification with Kite’s CSV procedures.

  • Drive computer system compliance aspects across Kite’s EU project portfolio.

  • Partner with the corporate QE department around automation strategies.

  • Support regulatory inspections and audits.

  • Manage the risk assessment process for computer system validation.

  • Provide technical response and expertise during audit and inspections for areas under responsibility.

  • Plan, schedule, and carryout project management of technical projects with cross-functional teams.

  • Help prepare and write relevant sections of IND and BLA documents.

  • Review technical/investigation reports as appropriate.

  • Review and approve proposed changes to systems and procedures, as appropriate.

  • Track, review and report metric information for use in continuous improvement of areas of responsibility.

  • Perform other duties as required.

Experience:

  • At least 8 years of Computer System Validation and Equipment Qualification experience in a GMP environment (Drug Substance or Drug Product).

  • Working knowledge of quality systems and regulatory requirements (EU GMPs, ICH 8, ICH 9, ICH 10).

  • Minimum 5 years of management experience.

  • Bachelor’s degree in technical discipline (Computer Science/Engineering or similar).

  • Experience in the medical and/or pharmaceutical industry.

  • Bilingual/Fluent in English.

Skills/Qualifications:

  • Automation, 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 principals.

  • Strong knowledge of change control practices/strategies.

  • Proficient in MS Word, Excel, Power Point and other applications.

  • Strong written and verbal communication skills.

  • Ability to communicate and work independently with scientific/technical personnel.

Would you like to know more before you apply? Please contact Jose van de Beek - Talent Acquisition Business Partner, via: CareersEU@kitepharma.com .

Only candidates in possession of a valid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

#LI-JV1

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead