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ERP Validation Lead, Senior Manager

Employer
Gilead Sciences, Inc.
Location
Raleigh, NC
Start date
Jun 26, 2022

View more

Discipline
Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details


Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization.

Please check out more at https://nccareers.gilead.com/

This position will be based in our new Gilead Business Services Center in Raleigh, NC. We will also consider candidates who will be based in Foster City, CA at our headquarters.

The ERP Validation Lead, Senior Manager will deliver business solutions in support of the organization. This involves partnering with business stakeholders, both operational and development teams, and IT teams and leadership. This role requires a combination of both technical and leadership skills. The role will provide guidance and oversight to technical staff. The ERP Validation Lead will provide strategic & operational expertise/guidance and thought leadership to SAP teams on compliance, validation, change management, deployment/release management and test strategy. Will be instrumental in developing and managing the strategy and overall approach for validation of ERP boundary ecosystem, including oversight of Validation Plans, Specifications, Testing Protocols (IQ,OQ,PQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports.

Essential Functions
  • Lead the validation lifecycle during the implementation of SAP systems, mergers, upgrades and validation of SaaS and Cloud applications.
  • Project change manager for ERP working to deploy SAP S/4 HANA in a greenfield environment and subsequently process SAP changes, fixes and upgrades.
  • Lead Validation Strategy for Boundary Applications in collaboration with Boundary App Validation leads
  • Schedule, plan and manage these changes through the entire life cycle of the change to include development, testing and implementation into the production environment.
  • Ensure audit readiness for GxP Audits and lead regulatory audits from validation perspective
  • Implement lean validation methods to reduce the time for validation lifecycle while increasing compliance posture
  • Lead and Collaborate effectively with a geographically distributed team.


Basic Qualifications:

10+ Years' Experience and Bachelor's Degree or 8+ Years' Experience with advanced Degree

Preferred Qualifications:
  • Hands on work experience with GxP regulations and standards (e.g. 21 CFR Part 11, EU Annex 11, GAMP, etc..)
  • Hands on work experience with SAP S/4 HANA Solution Manager and CHARM toolsets preferred
  • Extensive experience in driving risk-based validation strategy and leading testing strategies
  • Extensive experience delivering within a complex ERP Ecosystem
  • Experience delivering solutions using Agile DevOps is a plus
  • Working knowledge of tools such as AGILE, Trackwise as well as document repository tools such as Veeva.
  • Self-motivated, customer and delivery focused
  • Excellent written and verbal communication skills are required
  • Shows strong and balanced judgment based on thorough analysis of complicated difficult situation and clear understanding of the decisions' implications and impacts in and outside the department.
  • Excellent technical, analytical, and project management skills


Gilead Core Values:
  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)


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 Career Site: https://gilead.yello.co/job_boards/v42vD4vKxb3AkKvV93YsrQ

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.

Gilead and Kite Careers


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. 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' 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.








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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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