Executive Director of IT Quality and Compliance

Executive Director of IT Quality and Compliance
United States - North Carolina - RaleighUnited 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

For Current Gilead Employees and Contractors:

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Job Description


The Executive Director of IT Quality and Compliance will be a key member of IT Security, Risk and Compliance (SRC) team within Information Technology. This is a leadership role that ensures the delivery of IT quality and compliance responsibilities such as GxP, SOX, Quality, and Privacy to create a world class culture of quality and compliance.

Essential Duties and Job Functions

General responsibilities for this position will include (but are not limited to) the following:

• Oversee and manage the IT Quality and Compliance team to provide strategic direction and effective execution of quality and compliance through subordinate staff to:
  • Ensures IT is compliance with global regulations, guidance, and industry standards through the development and execution of quality and compliance strategies and plans that meet objectives within applicable regulations and guidelines.
  • Ensures the conception, collaboration, and implementation of actions, processes, and behaviors within the mandate that ensure the integration of compliance areas, e.g., GXP, SOX, Privacy.
  • Ensures quality and compliance are integrated into operations and develops and implements a common platform of quality and compliance systems, tools, procedures, and standards to support it.
  • Ensures inspection readiness internally and externally through effective administration of the IT quality system
  • Ensures the state of IT Quality and Compliance is visible to IT leadership and the broader organization through quarterly reviews and other communication.
  • Ensures alignment among Gilead quality and compliance organizations by building and fostering solid business partnerships.
  • Assesses the effectiveness of the department, including the people, processes, and technologies needed to achieve departmental and corporate goals. Transforms problems and opportunities into actions and solutions that improve qualitative and quantitative performance.
• Supervises and supports the:
  • Global Head of IT Quality Engineering and ensures the definition and delivery of the IT Quality Engineering practices of computer systems validation, software quality assurance, infrastructure qualification, automation, and performance engineering for Gilead Sciences.
  • Global Head of IT Quality to ensure the definition and delivery of the IT Quality practice in compliance with global health authority regulations, guidance, directives, standards, and current industry best practices. These include QMS, CAPA, document management, etc.
  • Global Head of IT Privacy to ensure the definition of a Privacy framework and its operations, e.g., incidents, escalations, and assessments. is created and to privacy incidents, escalations. This includes representing issues to executive leadership and collaborating with the Legal Privacy Officer.
  • IT SOX function to ensure the scope and design of Internal Controls over financial reporting (ICFR) specific to IT systems is compliant with Sarbanes-Oxley Act (SOX) while supporting an efficient and effective process.
• Collaborate with senior leadership and stakeholders internally and externally to provide strategic and technical leadership within the quality and compliance space
• Acts as the primary liaison and coordinates meetings with regulatory agencies/inspectorates as needed, representing IT with those agencies.
• Lead and evolve the quality and compliance function ensuring global regulatory, industry, and corporate standards are met while creating a culture of continuous process improvement.
• Build a culture of innovative thinking that leads to the development and implementation of Gilead's mission and vision.
• Provide support, mentorship, and guidance to quality and compliance staff to ensure staff can independently make sound strategic and tactical decisions.
• Develop the technical, regulatory, and leadership of direct reports and ensures staff stay abreast of industry developments, including forthcoming regulations, guidance, and best practices.

Education

• Bachelor's or Master's degree in computer science, business administration or related field, or equivalent work experience.
• CISA certification is a big plus.

Experience

• 16 or more years in IT and business/industry or 14+ years within Masters or PhD.
• A minimum of 8-10 years of leadership responsibilities.
• At least 12 years of experience in quality and compliance areas.

Knowledge and Skills

• Pharma experience a must

• In depth knowledge of global health authority regulations, guidance, directives, standards, and current industry best practices relevant to IT quality, compliance, data privacy and data integrity and SOX.
• Fundamental understanding of global privacy laws and impact to business functions.
• Have a clear understanding of the global Vendor Risk Assessment, Privacy Impact Assessment, and Security Architecture Assessment processes, system functionality and business need to be involved in strategic direction/changes and approval of risk exceptions.

• Solid understanding of quality engineering including leadership experience in computer systems validation, infrastructure qualification, software quality assurance
• Experience delivering quality engineering services in a managed service provider (MSP) model including selection, transition, operations, and oversight
• Demonstrated understanding of software engineering industry best-practices, techniques, and tools (e.g., Scrum, DevOps, Agile)
• Solid understanding of performance engineering and automation
• Strong leadership capability, executing as appropriate in the areas of responsibility
• Expertise in budget planning, financial management, and workforce management
• Broad knowledge of current and emerging technologies, technology directions and strategic application to business needs including the ability to differentiate between a relevant trend and hype
• Ability to improve operational efficiency, service delivery, and information management across the IT organization
• Excellent oral and written communication skills, including the ability to explain technology solutions in business terms, establish rapport and persuade others

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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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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.

For Current Gilead Employees and Contractors:

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






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