IT Quality Engineering Associate Director
4 days left
- Organization Type
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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionGilead 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 SkillsProvides 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 QualificationsAssociates Degree and Twelve Years Experience OR Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' ExperienceKnowledge, Experience and SkillsExpert 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 ITIL7+ years of hands on work experience within Pharmaceuticals, Biotech or Life Sciences industriesExperience and ability to lead and drive process improvement initiatives in the quality spacePossesses knowledge of common IT infrastructure services and IT computerized systems in pharmaceutical environmentExpert 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 Q9Expert knowledge and experience with application of CAPA (corrective action preventative action) methodology including structured approach for failure investigation and identification of root causeExperience in directing Managed Services personnel within multiple QMS areasExcellent communications and writing skills; has experience with application of good documentation practices and document control principlesHave a common sense approach to quality and complianceInnovation and Process Improvement mind set Gilead Core ValuesIntegrity (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 firstname.lastname@example.org for assistance.For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.