Sr. IT Quality Engineering Manager, Quality Assurance

Location
Raleigh, NC, United States
Posted
Feb 26, 2021
Ref
2166317
Required Education
High School or equivalent
Position Type
Full time
Sr. IT Quality Engineering Manager, Quality Assurance
United States - North Carolina - Raleigh

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization.

The Sr. IT Quality Engineering Manager, Quality Assurance position provides Quality Assurance oversight for corporate IT infrastructure, platforms and applications used in support of GxP computerized systems and operations company-wide. Works with IT Security, Risk and Compliance management to ensure internal procedures for IT Qualification and Validation are followed and remain effective at delivering compliant IT systems.

Specific Responsibilities:
  • Owns quality oversight to the functional areas as deemed by the IT Quality Management
  • Works as part of IT project and operational change control teams to provide oversight and compliance approvals of project deliverables; IT change requests, deviation and CAPA
  • Provide oversight and approvals of risk assessments related to IT systems
  • Provides guidance to IT department staff on interpretation and application of IT procedures applicable to the implementation and operation of qualified IT infrastructure and validated systems
  • Drives process improvements across quality functional areas and act as change agent for quality process improvements
  • Interfaces with compliance groups outside of IT and supports internal compliance audits; audit follow up and remediation of audit findings related to IT Infrastructure and Computerized systems as applicable
  • Works with project managers to establish work scheduling plans in support of project schedules and participates in project meetings


Basic Qualifications:

High School Degree and Twelve Year's Experience OR Associates Degree and Ten Year's Experience OR Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience

Preferred Qualifications:
  • Advanced proficiency and expert in GxP computerized system lifecycle management and has experience in the application of industry good practice, e.g., GAMP Good Practice Guide: IT Infrastructure Control and Compliance and ITIL
  • Excellent communications and writing skills; has experience with application of good documentation practices and document control principles
  • Experience in driving process improvement initiatives in the quality space
  • Possesses working knowledge of common IT infrastructure services and IT computerized systems in pharmaceutical environment
  • Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9
  • Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause
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 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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