Senior Quality Engineer

职位描述

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

As a Senior Quality Engineer, you’ll be joining a team in which people of diverse backgrounds and experiences are respected and are working together focused on saving lives by finding the cure for cancer. You will report to the Senior Manager of Quality Engineering of the manufacturing plant in Hoofddorp (TCF04).

Your profile

• Provide quality oversight for network and local computer systems validation, enterprise systems and IT infrastructure, in providing approach, methodology and deliverables in compliance with GMP regulations, 21 CFR Part 11, EU Annex 11 and Data Integrity guidelines.
• Identify industry trends and look for opportunities to leverage best practices to improve future state processes. (e.g. CSA, Paperless lab, AI)
• Drives use of best-practices during IT infrastructure design, validation, and use based on Kite Policies and procedures, cGMP, data integrity and risk based practices.
• Collaborate with IT, OAT, QC and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
• Provide Quality input, oversight and approvals for validation documents to ensure Quality, Data integrity and compliance to Kite procedures.
• Supports the review and approval of quality system management records (Change Controls, Deviations, CAPAs) as required.
• Ensures the application of data integrity regulations and guidelines from governing agencies when participating in site and global projects related to computerized systems.
• Support risk-based approach to qualification of computerized systems.
• Quality oversight of validation documents (Validation plan, SIA,URS, IOQ , Traceability Matrix etc.) with functional teams, ensuring the documentation meets compliance requirements and quality standards.
• Drive continuous process improvement in the area of computer system validation, enterprise systems, IT infrastructure and data integrity
• Support the team when needed in CQV quality oversight activities and Quality Risk Management oversight activities for the site (in house training will be provided)

Your new role

• BSc degree in Science, Engineering, Computer Science to relevant scientific field.
• Previous experience in FDA/EU regulated environment with good understanding of GxP standards, IT infrastructure compliance, Risk based validation and cGMP manufacturing for biotech/pharmaceuticals.
• Knowledge of EU and FDA guidance’s, regulatory regulations and industry standards on computerized systems in pharmaceutical industry
  (i.e., Quality Systems, GAMP5, 21CFRPart11 and EudraLex Volume 4 Annex 11).
• Experience with the creation, review, and execution of qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of exceptions/deviations.
• Strong knowledge of GAMP and Data Integrity industry requirements and how they apply to IT.
• Experience in CQV and Quality Risk Management is a plus

Your soft skills

• Ability to think critically and utilize troubleshooting and problem-solving skills.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Excellent interpersonal, verbal and written communication skills and ability to work in collaborative and fast paced work environment.
• Has demonstrated the following leadership behaviors: Ethics & Integrity, Focus on Customers, Drive Results, Build Talent, Collaborate.
• Excellent interpersonal and communication skills.
• Strategic thinking.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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