Capability Manager, Head of Validation

Location
Raleigh, NC, United States
Posted
Feb 26, 2021
Ref
2166323
Required Education
Bachelors Degree
Position Type
Full time

Capability Manager, Head of Validation
United States - North Carolina - Raleigh

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, 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.

The Capability Manager, Head of Validation is responsible for assuring and continuous improvement of organizational wide standards for the Computer Systems Validation quality engineering practice. Defines and implements technology and process roadmap, and transformation or service enhancement for IT QE. Partners with business and IT to ensure delivery is compliant through assessments, consulting, coaching, and advising.

Responsibilities include:

 

  • Defines and maintains the principles and practices of Computer Systems Validation to ensure quality and compliant delivery to the business
  • Maintains awareness of industry best-practices and standards
  • Applies global health authority regulations, guidance, directives, standards, and current industry best practices to ensure quality and compliant delivery to business
  • Defines and implements the technology and process roadmap for Computer Systems Validation
  • Identifies, defines, and implements transformation/service enhancement for IT Quality Engineering
  • Identifies best practices and bad practices for incorporation into Quality Engineering knowledgebase
  • Acts as a subject matter expert in discussions and communications during audits and inspections
  • Identifies, implements, and maintains tools and best practices to enhance software development productivity and management
  • Partners with business quality assurance units
  • Collaborate with regulatory specialists in Legal, Quality and Compliance to develop IT methodology to implement compliance in an efficient manner.
  • Provides consulting, coaching, and advising for verticals and horizontals to assure GATES requirements are achieved.
  • Ensures company's quality/compliance standards are met through Assessments to Engineering Standards (GATES) and postmortems.
  • Evaluates return on investment to ensure effective and efficient use of validation
  • Evaluates activities and deliverables to ensure results align with company's requirements and metrics needs
  • Advocates best practices across projects, portfolio, and deliverables
  • Serves as a resource to project team on regulations related to testing and documenting computerized systems. Seen as a technical resource in the testing and validation team on testing tools and methods

 


Basic Qualifications:

Associates' Degree and Fourteen Year's Experience OR Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience

Preferred Qualifications:

 

 

  • 10 + years of hands on IT Quality Engineering experience
  • Strong background and leadership experience in validation, infrastructure qualification, and/or software quality assurance
  • Experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is required, such as biopharmaceutical business process knowledge and applicable computerized systems (e.g., research development, manufacturing, clinical research, quality systems)
  • Working knowledge of global regulatory requirements of GMP, GCP, GLP, GDP and/or other domains
  • Must possess excellent technical writing, documentation, training, and communication skills
  • Strong background in SDLC, GAMP, and testing
  • Working knowledge of Scrum, DevOps, and Agile desirable
  • Broad knowledge of quality principles and industry trends
  • Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals
  • Ability to develop and maintain effective relationships with internal and external stakeholders
  • Experience with Managed Service Operations including leading and influencing onshore and offshore development and testing teams
  • Strong collaboration skills required to effectively work across a diverse group including executives, managers and subject matter experts (SME)
  • Prior experience in inspection support roles/knowledge of audit process desirable
  • Has a strong working knowledge of the testing process, designing test scenarios and test scripts, including of understanding of various software quality practices, with the ability to learn and apply new and emerging concepts very quickly.
  • Has experience with structuring the testing tasks on multiple projects, estimating schedules, resources and dependencies.
  • Demonstrated expert understanding of relevant application development processes including the project management methodology, serving as a resource to others.
  • Demonstrated breadth and depth in information technology and/or pharmaceutical industry experience with exposure to a broad range of GxP validation activities such as document control, computer systems, vendor assessment, and change control.
  • Demonstrated breadth and depth experience performing testing and system validation work in a GxP environment.

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:
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