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Director, R&D Information Systems

Employer
GILEAD Sciences
Location
San Mateo County, CA
Closing date
Jan 27, 2023

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Sector
Other
Organization Type
Corporate
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:
  • Lead Product Lifecycle Management (PLM) capabilities which include management of data and processes supporting clinical studies, product development, new commercial product introduction to worldwide markets, manufacturing operations, supply of product, product changes and regulatory filings / amendments, and product sunset.
  • Lead creation and management of data elements and structure for unique identification and exchange of regulated drug product and drug substance information. Example of product defining data and their attributes include product name, National Drug Code (NDC) numbers, Global Trade Item Numbers (GTIN), shelf-life, units, strength, dosage form, product packaging, labeling, and marketing authorization.
  • Ensure product structures are maintained associating raw materials, regulatory starting materials, intermediates, finished goods together along with as applicable their bill of materials, recipes, formulas, labels, packaging, site qualification information, and approved manufacturing sites.
  • Lead management of non-GxP and GxP supplier information used in the purchase of materials; testing and storage of intermediates, API, products or excipients; and the manufacture of Gilead drug substances and drug products. Maintain supplier status according to supplier audit outcomes, qualification statuses, and business partnership decisions. Maintain approved supplier lists and supply chain tables in support of EU GMP Annex 16 Qualified Person Certification and Batch Release requirements.
  • Responsible for digital management of registration specifications and analytical specifications used to determine acceptance criteria and release product. Support jurisdiction control data management and the application of jurisdiction controls in the release of drug product to the appropriate and intended market(s).
  • Responsible for management of regulatory information capturing approved product registration information and Chemistry, Manufacturing, and Controls (CMC) information by product and country or market/
  • Develop and advance product management roadmap to enable knowledge management and collaboration internally and with external contract partners. Stay current with product management trends and maintain the capability roadmap to help PLM capabilities remain current, competitive and aligned with Gilead's strategic direction.
  • Coordinate change events and connect product information between systems
  • Provide leadership during regulatory inspections and audits to explain controls in the management of product data. Support quality assurance investigations as needed in deviations
  • Work with Enterprise IT and business stakeholders to implement infrastructure, platforms and applications to improve the efficiency of application management, speed of deployment, operational resilience and improved regulatory compliance.
  • Responsible for working with PDM (Pharmaceutical Development & Manufacturing) organization and related business partners to facilitate the governance of business processes and enterprise data standardization.
  • Develop and execute operational metrics and dashboards. Align with other analytics and business intelligence initiatives in the laboratory, quality, manufacturing, supply chain and outsourced operations.

Essential Duties and Job Functions:
  • Lead team of full-time and contract technical professionals to support technical development, manufacturing operations, supply chain, and regulatory affairs activities
  • Provide matrix leadership and influence across different functions within the Gilead organization covering strategy and architecture, system management, process management, cGxP validation, analytics, data integrity.
  • Develop key performance indicators to measure the effectiveness of initiatives and operations.
  • Manage relationships of vendors and service providers. Develop managed services model, conduct cost-benefits analysis, establish the success criteria, execute, measure and report results.
  • Establish methodology to collect requests for IT tools, organize, evaluate, prioritize and establish a department portfolio. Ensure that portfolio is consistent with organizational objectives, corporate standards, the technology roadmap and the changing regulatory compliance landscape.

Knowledge, Experience and Skills:
  • Have a broad knowledge of product management concepts, practices, standards in the USA and international.
  • Familiar with Identification of Medicinal Products (IDMP) ISO standards and experience with the components of IDMP - regulated medicinal and pharmaceutical product information, substance identification, dosage form and route of administration, and unit of measurement
  • Knowledge of solid oral dose, injectables, small molecule, biologics, combination product, multi-pack considerations in product management and lot management context
  • Have a broad knowledge of cGMP principles, concepts, practices, standards and data integrity assurance with worldwide health authorities. Be current with regulatory guidances, industry standards, and jurisdiction controls
  • Knowledge and experience with new product introductions, product change processes, and product sunset.
  • Knowledge of process management, change control, collaboration, knowledge management, financial management, operations, project delivery, analytics and metrics.
  • Possess strong abilities to manage, develop and improve people, processes, operations and technology. Drive for excellence, develop team and manage for success. Provide solutions to highly complex problems and apply a high degree of ingenuity, creativity and innovation.
  • Create documented rationale to explain and defend technical, organizational and control strategies to support regulatory compliance. Effectively interact with regulatory compliance agencies as needed and represent Gilead in public forums.
  • Work with IT, service providers, system architects, project managers and vendors to develop budgets and monitor expenditures.

Basic Qualifications:
  • 12+ years of relevant experience and a Bachelor's degree in science or related fields. OR 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
  • Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Prior people management experience.
  • Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial.
  • Biopharmaceutical or Pharmaceutical experience preferred.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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.
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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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.
Summary
  • Location: United States - California - Foster City
  • Type: Full time
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