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Gilead

Sr. Manager Serialization and Manufacturing

For Current Gilead Employees and Contractors:

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

Job Description

At Gilead, we strive to transform the promise of science and technology into therapies that have the power to cure, prevent or treat disease. As a research-based biopharmaceutical company, we are revolutionizing healthcare by bringing medicines to patients in the areas of HIV, AIDS, liver diseases, hematology and oncology, and inflammation and respiratory diseases. 
We are growing a diverse team of professionals and an atmosphere of inclusion across departments. We need your unique talents, expertise and background to help millions of people around the world live healthier. Join a close community where every voice is heard – where you can see and measure the results of your contributions.
Our values – integrity, inclusion, teamwork, accountability and excellence – are evident in everything we do.

The IT Serialization / Manufacturing Solution Development group is responsible for delivering and supporting IT solutions in collaboration with global functional business partners and IT Business Engagement. The Sr. Manager IT Serialization and Manufacturing is responsible for solution architecture, design, build, deployment and support of business applications globally. The role requires strong management experience to work with Business Engagement, service providers, application owners and functional business partners in supporting the Commercial and Clinical Manufacturing business in areas such as Serialization, Supply Chain, Manufacturing, Packaging and distribution of Gilead products.

Essential Duties and Responsibilities:

  • Serves as a Technical lead on serialization and commercial manufacturing initiatives. This includes owning and leading, functional and technical design, architecture, implementation and testing following the Gilead methodologies for the software development process.
  • Partner with Business Engagement teams to craft the business case to Deliver Projects to support the Business strategy.
  • Lead and partner with the Implementation Vendor to ensure the effective execution of projects and services, holding them accountable to the project scope, SLA's and critical metrics.
  • Responsible for governing level 3, 4, and 5 stack applications represented in Serialization and Manufacturing ISA-95 architecture models.
  • Act as a domain authority on Serialization and Manufacturing IT solutions and systems, primarily responsible for maintaining and being responsible for the associated systems in accordance with Gilead policies.
  • Leading functional Serialization and Manufacturing resources accountable for project work estimates. This includes developing high level proposal with timelines, tasks and resources associated for a project. Anticipates change and advances accordingly.
  • Provides direction, functional mentorship and inputs to technical teams on complex requirements/ development, configuration and implementation efforts, improving the expertise of IT colleagues.
  • Support Validation/QA teams on ensuring GxP compliance of serialization and other commercial manufacturing systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.

Skills And Qualifications:

Must have validated implementation experience of serialization in a Bio-pharmaceutical industry.

  • Laser focused and strong delivery experience balancing large, complex projects.
  • Familiar with systems such as Oracle, SAP, Werum Pas-Xand integration systems like Oracle SOA Middleware, Dell Boomi
  • Experience on GxP applications (and good Documentation Practices) and working in SOX audited environments is a plus.
  • Experienced with functional/technical implementation supply planning applications based on the functional designs.
  • Have minimum 8 years of IT experience supporting Supply chain, Manufacturing and Operations business functions.
  • Track record working in a dynamic, highly iterative environment
  • Communication – able to communicate complex solutions and values in business terms to the business partners. Social skills are critical to adapt and learn the changing business environment and domains that are required.
  • Must have 3+ years of Track and Trace, EPCIS application Solution Design, implementation and integration experience with ERP (such as Oracle/SAP) and packaging execution systems (such as Systech or Antares or Optel).
  • Must have 3+years of MES (Manufacturing Execution Systems) experience with Electronic Batch records, Weighing Dispensing, Master Batch Records, Material flow and Inventory.
  • Must have project/applications lead experience running small to medium-sized global projects in the manufacturing area as well as multi-functional experience leading a diverse group of individuals ranging from technical (internal or external), business users, validation, QA, and collaborating with project managers driving tasks to completion.
  • Have a solid grasp of installed systems, with the ability to seek and resolve many problems on the existing system(s) supported and is aware of integration points with other systems.
  • Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.

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: https://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf

Notice: Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Your rights under the Family and Medical Leave Act: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

Pay transparency nondiscrimination provision: https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

RSRGIL

#LI-MP4


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.

Apply Now

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