Senior Associate, Centralized Process Team (CPT)

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 17, 2023

Job Description:

Senior Associate, Centralized Process Team (CPT)
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

For Current Gilead Employees and Contractors:

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

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description

POSITION OVERVIEW:

The Business Process Excellence (BPE) Group works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process development, controlled documentation and learning programs. In addition, the Incubation Hub will include oversight of all RSQ initiatives involving GRA and initially will include the establishment and implementation of the Regulatory Clinical Trial Application (CTA) Group. The wider BPE team, incorporating the Centralized Process Team (CPT) and dedicated staff responsible for Regulatory Learning & Development, will partner closely across GRA and the wider Gilead organization to provide various services including, but not limited to GRA business process support, audit readiness support, process improvement support and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications and regions. The team will also identify, lead and implement ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities across the global organization (US, EU, Japan, China, Australia, Canada, Intercontinental and Global Patient Solutions).

EXAMPLE RESPONSIBILITIES:

• Supports the development of the Centralized Process Team
• Performs independently as executing project manager for improvement initiatives, deviations/CAPAs, and procedural document creation, updates, and obsoletion
• Works with project lead and stakeholders to ensure project framework, objectives, and milestones are aligned with business objectives
• Drives continued team progress on multiple procedural document updates and projects during and between meetings through meeting follow-ups, conversations, and emails
• Schedules deviation/CAPA team meetings, creates meeting minutes, develops next steps/action items, and updates the Quality Management System
• Trains and mentors junior employees/contractors on procedural document, deviation/CAPA, and GxP training systems use
• Acts as a Regulatory Affairs procedural document, deviation/CAPA, and GxP training lead
• Monitors GxP training compliance reports to ensure on-time completion
• Supports people managers in their direct reports GxP training assignments
• Leads the development and implementation of a tracking tool for RA training lists of procedural documents
• Leads the development and implementation of a tracking tool for RA procedural documents for routine reviews and required updating
• Leads the development and implementation of a tracking tool for RA CAPAs to ensure communication between Compliance and RA functional representative
• Actively participates in RA Business Process Excellence Team activities.
  REQUIREMENTS:
  
  We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
  
  Minimum Education & Experience
  • 5+ years of relevant experience with a Bachelor's Degree
  • 3+ years of experience in the biotechnology or pharmaceuticals industry with MA/MS/MBA
  • Familiarity with quality management systems (QMS) or similar platform
  • Experience with Six Sigma or other process improvement methodologies
  • Experience managing and collaborating with virtual or remote teams
  • Experience with SharePoint administrator activities
    Knowledge & Other Requirements
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
    • Fluency in project management platforms/software
    • Familiarity with highly regulated industry environments or drug development
    • Excellent program and project management, consensus-building, and leadership skills
    • Exceptional verbal and written communication skills and interpersonal skills
    • Ability to collaborate across the organizational hierarchy and cross-functionally
    • Experience managing teams in a business operations or technical processes environment
    • Demonstrates strong attention-to-detail and good organizational skills
    • Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality
    • Ability to quickly learn new software, regulations and processes
    • Ability to work independently on basic job duties and understands criticality and time expectations of assigned activities and prioritizes as appropriate
    • Displays flexible thinking and willingness to adapt to changing approaches based on project needs and expectations
    • Capable of using advanced functions of various software applications, particularly the Microsoft Office Suite, Adobe Acrobat, and SharePoint
    • Ability to support a team-oriented, highly-matrixed environment
    • Ability to lead and influence programs, projects and/or initiatives
    • Ability to execute multiple tasks as assigned
      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 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 'Know Your Rights' 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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Keywords: Gilead Sciences, Inc., San Mateo , Senior Associate, Centralized Process Team (CPT), Other , San Mateo, California