Associate Director: Supply Chain (Global Serialization & Traceability)

Location
Foster City
Salary
See job description.
Posted
May 06 2021
Ref
R0019359
Position Type
Full Time
Organization Type
Pharma


Associate Director: Supply Chain (Global Serialization & Traceability)
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. Gileads 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 companys five core values. Thats 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


Associate Director: Supply Chain (Global Serialization & Traceability)

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's contribution 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.

Job Overview:

This role will serve as the business lead for several projects in Gilead's Global Serialization & Traceability organization and be the global business process owner for the enterprise serial number management system (SAP Advanced Track & Trace for Pharmaceuticals). In this role the individual will be responsible for leading teams that manage roadmap initiatives and projects. These global business processes are applicable to both internal sites and business functions and external secondary packaging CMOs & 3PLs.

Job Responsibilities:
  • Lead and support the interpretation of both emerging and changing global serialization & traceability regulations, industry standards (e.g. GS1) and subsequently determining the impacts of these possible changes to our related systems and business processes. The scope of the analysis and related work will be across all sites, functions and CMO's that support Gilead's serialization & traceability related business processes (current or future).
  • Perform capability assessments and identify gaps to either justify:
    • A new capital project or
    • A change order to an existing in-flight capital project or
    • Incorporation of the change via operational support
    • Assigning the activity as appropriate to the serialization & traceability portfolio (priority, timing, resources, costs)
  • Manage assigned global cross-functional strategies and activities associated with the implementation and management of these serialization activities for all commercial products across all manufacturing sites including all contract manufacturing organizations (CMOs).
  • Represent Gilead's Serialization & Traceability function on global teams and initiatives as the business owner.
  • Provide business process ownership and support of Gilead's Serialization Level 4 (enterprise) systems and operational processes.
  • Manage the completion of business process and system regression testing as required by Gilead's IT validation processes.
  • Assess the impact for any new product launches or packaging / labeling changes, identify and manage completion of tasks to address any gaps.
  • Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables.
  • Provides leadership, direction and management of a team, to support execution of the Global Serialization and Traceability strategy.
  • Provides oversight, guidance and management of personnel working on assigned projects and operational support processes.
  • Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance.
  • Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
  • Develops and implements policies and procedures for the operation of the Global Serialization & Traceability activities, ensuring all relevant regulatory requirements are met.
  • Develops and implements strategies and goals for specific products or projects.
  • Creates and effectively communicates supplier, subcontractor and/or vendor agreements and opportunities to the organization.
  • Implements and maintains serialization systems, policies, processes and procedures ensuring compliance with regulatory requirements.
  • May serve as liaison between the company and the various governmental agencies and/or audit agencies as required.
  • Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents or position papers.
  • Negotiates large contracts involving substantial financial amounts. Monitors cost, schedules and performance aspects of major contracts. Drives cost savings through direct negotiation and other sourcing methods.
  • Reviews and provides feedback on serialization and traceability requirements in quality agreements.
  • May execute supplier agreements in conjunction with Legal and internal clients to ensure contracts terms and conditions are in compliance with corporate and purchasing guidelines.
  • Conducts formal business reviews with key suppliers, subcontractors and/or vendors to discuss performance on a regular basis. Manages against contract performance to ensure that agreed upon cost, service, quality, schedule and flexibility goals are met.
  • Compiles information from regulations, periodicals, catalogs, and other sources to keep informed on relevant market and competitor information.


Knowledge & Skills:
  • Serialization and traceability expertise in a GMP environment including an in-depth understanding of SAP ATTP and the end to end serialization & aggregation architecture from the packaging operations, warehousing, distribution and communication to both downstream trading partners and government systems.
  • 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.
  • 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.
  • 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.
  • In-depth understanding of current serialization & traceability regulations including US DSCSA, EU FMD and Brazil ANVISA.
  • 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 an in-depth understanding of the financial management for projects and department budgets.
  • Demonstrates in-depth knowledge and proficiency across multiple practices within Supply Chain and Commercial Manufacturing departments, to understand, coordinate and communicate competing demands.
  • Ability to collaborate cross-functionally.
  • Experience in a pharmaceutical operations/cGMP environment highly desirable.


Minimum Qualifications:
  • 10+ years relevant experience in related field and a BS or BA; or
  • 8+ years of relevant experience in a related field and a MA/MBA.


To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer.

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:

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


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Director--Supply-Chain--Global-Serialization---Traceability-_R0019359





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