Sr. Manager, Product Authentication Digital Capability Business Process Owner & Lead
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
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 DescriptionDescription
GVerify is Gilead's instance of the Securikett's Codikett® Digital Authentication Tool, a multi-layered cloud-accessible IT tool that supports supply chain security using tamper evident product seals with embedded encrypted Quick Response (QR) codes for use in assuring product authenticity. GVerify allows for the monitoring and notification of these authentication events. The GVerify system manages the process for serial number creation and provisioning, master data creation and management, serial number activation and association, end user education and serial number verification, alert management, and data analytics.LocationFoster City preferred - open to remote for the right candidate.Job TitleSenior Manager Product Authentication Digital Capability Business Process Owner & LeadJob Description R&R
The Product Authentication Digital Business Process Owner is responsible to define the scope, the business requirements, and the ancillary business resources for GVerify including the engagement with other business areas that may be required to execute ongoing business as usual tasks and/or lead projects to extend this capability per business requirements. They are responsible for ensuring that all business processes, business resources and procedures are in place for all areas impacted by daily operations or by a specific project. Job Responsibilities
Knowledge & Skills
- Lead and manage business team resources for operational and sustainment project tasks supporting Gilead's Global Anticounterfeiting Team initiatives and other projects as required
- Lead and support the interpretation of both emerging and changing global anticounterfeiting goals and determine the impact to Gilead site and global GVerify systems and processes.
- Provide business process ownership and support of GVerify systems and operational processes.
- Provide business process ownership, support, and change management for the implementation and associated testing of GVerify process and system improvement projects with associated sites.
- Provide oversight and guidance to personnel working on GVerify assigned projects and operations support processes.
- Represent GVerify function on global teams and initiatives
- Assess and document the impact for any new product/sites/markets launches and packaging/ labelling changes. Develop requirements, identify, and manage completion of tasks and / or projects to address any gaps
- Develop and provide training for the operation and use of GVerify across all sites, functions and CMOs that use GVerify related business practices.
- Implement and maintain GVerify systems, processes and procedures ensuring compliance with regulatory and quality requirements
- Serve as liaison between the company and the various governmental agencies and/or audit agencies as required regarding GVerify
- Review, and/or implement changes to controlled documents as needed
- Develop and maintain country/language specific GVerify response pages, Gilead public internet product and FAQ web pages, and local market communications/training documents
- Coordinate the language translation of GVerify response pages, Gilead public internet product and FAQ web pages and local market communication/training documents
- Triage GVerify system and process issues with GVerify technical team and vendor support
- Provide GVerify support to Global Packaging Engineering and Gilead Packaging Network
- Develop and maintain product master data in GVerify
- Develop and maintain product/language specific artwork in the Amazon Web Services cloud repository
- Provide GVerify data analytics, reports and metrics, as requested
- Coordinate GVerify system use with current and future site business users
- Drives strategy for current and future business use of the GVerify digital authentication tool.
- Responsible for providing budgetary information in support of the LE financial process
- Coordinates the development of SOWs and POs in support of the GVerify program
- Assumes business process ownership of new capabilities, as required
Education & Experience
- Brand Protection expertise in a GMP environment including an in-depth understanding of Codikett, or similar technology, and the end-to-end business process from the incoming inspection, packaging operations, quality release, and communication to both downstream trading partners and governmental agencies.
- Able to develop solutions to a wide range of complex problems, which require the regular use of ingenuity and innovation.
- Exceptional verbal and written communication skills. Able to create written communication that is properly structured providing clear, concise messages that draw well supported conclusions and recommendations.
- Promotes and demonstrates continuous improvement throughout the organization
- Strong negotiation skills.
- Good organizational and time management skills, including working knowledge of basic project management tools and techniques.
- Ability to interact effectively with senior management.
- Understanding of SaaS software validation processes and GAMP principles.
- In-depth understanding and application of relevant principles, concepts, practices, and standards, along with an in-depth knowledge of industry practices and regulations.
- Solid working knowledge and expertise of relevant US, EU and international pharmaceutical cGMPs/ regulations and personal information privacy laws.
- Able to apply established organizational policies, and interpret, execute and recommend modifications to department policies and procedures as needed.
- May require familiarity with the technologies, strengths and weaknesses of a wide variety of secondary packaging capabilities and manufacturers worldwide.
- Demonstrates in-depth knowledge and proficiency across multiple practices within Supply Chain and Commercial Manufacturing departments, to understand, coordinate and communicate competing demands.
- Interfaces with external vendors, suppliers and contract manufacturers to address and resolve more complex product/process performance issues. May participate in proposal review, price negotiation and supplier selection.
- Ability to collaborate cross-functionally
- 8+ years relevant experience in related field and a BS or BA; or
- 6+ years of relevant experience and a MA/MBA.
- Experience in pharmaceutical operations/cGMP environment highly desirable.
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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 email@example.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 'EEO is the Law'
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.