IT Quality Engineering Associate Director

Location
Foster City, CA
Posted
Jul 21, 2021
Ref
2312642
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
IT Quality Engineering Associate Director
United States - California - Foster City

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

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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. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. This is the focus of the Access Operations & Emerging Markets business unit, spanning more than 130 resource-limited, low, lower-middle and upper-middle income countries across Latin America, Africa and Asia.

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually, and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

Specific Responsibilities and Skills
  • Provides day-to-day management and oversight of a single operational group or technical team performing similar services/activities.
  • Develops and implements annual plans, programs, and objectives for the unit.
  • The individual in this role provides and manages a team that provides Quality Assurance oversight for corporate IT infrastructure, platforms and applications used in support of GxP computerized systems and operations company-wide.
  • Established partnerships 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.
  • 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.
  • Manages and drives process improvements across quality functional areas and act as change agent for quality process improvements.
  • Establishes partnerships with compliance groups outside of IT and hosts and manages internal compliance audits.
  • In partnership with project managers, align resource to plans in support of functional and global projects and initiatives.
  • Manages multiple projects, within their technical discipline.
  • Develops or ensures the development of accurate and thorough forecasts.
  • Establishes plans that prioritize initiatives, based on an understanding of the needs of the business.
  • Anticipates conflicting needs within their functional area and proactively resolves them.
  • Integrates resources effectively, including resources under direct control, or controlled by contractors, vendors, etc.


Basic Qualifications
Associates Degree and Twelve Years Experience OR Bachelor\'s Degree and Ten Years' Experience OR Masters\' Degree and Eight Years' Experience

Knowledge, Experience and Skills
  • 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
  • 7+ years of hands on work experience within Pharmaceuticals, Biotech or Life Sciences industries
  • Experience and ability to lead and drive process improvement initiatives in the quality space
  • Possesses knowledge of common IT infrastructure services and IT computerized systems in pharmaceutical environment
  • Expert knowledge with conducting and managing risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9
  • Expert knowledge and experience with application of CAPA (corrective action preventative action) methodology including structured approach for failure investigation and identification of root cause
  • Experience in directing Managed Services personnel within multiple QMS areas
  • Excellent communications and writing skills; has experience with application of good documentation practices and document control principles
  • Have a common sense approach to quality and compliance
  • Innovation and Process Improvement mind set


Gilead Core Values
  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)

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:

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