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Manager, Project Management - cGMP Projects

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Feb 13, 2024

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Job Details

Manager, Project Management - cGMP Projects
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 #CreatingPossible

For Current Gilead Employees and Contractors:

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

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description



The Project Manager, Corporate Engineering and Facilities will act as the Project Manager for assigned projects. You will develop and manage project plans and manage project timelines, communications, meetings, and other interactions to ensure project deliverables are met on-time, to the quality expected, and within-budget. You will represent the Project Team to various partners and stakeholders. As assigned, you will also develop and lead continuous improvement and optimization initiatives that may have impact across Corporate Engineering and Facilities - Project Management. You may be assigned cGXP and non- cGXP responsibilities.

Knowledge and Skills:

To ensure success in this position, we are looking for an individual who possesses the following knowledge and experience:
  • Solid knowledge base in cGMP and/or GMP Annex 1, with direct experience in managing and executing Cx and validation (e.g., manufacturing facility IOQ, PQ).
  • Training and experience in cGxP quality compliance such as identifying, writing and processing deviations, investigations, CAPAs using electronic document management systems (e.g., Trackwise).
  • Strong project management skills and proven experience in managing capital projects with emphasis on biopharmaceutical cleanroom facility and laboratories in a cGxP/Annex 1 environment.
  • Strong understanding of CQV process and direct experience in outlining detailed (day or hour) work breakdown structure/schedule.
  • Knowledge of critical building utility systems such as HVAC, BMS, compressed air/gases, WFI, RODI, vacuum, and waste systems.
  • Demonstrates an in-depth understanding and application of cGXP principles, concepts, practices, and standards in the US and internationally.
  • Demonstrates solid knowledge and good proficiency in MS Office applications (including MS Project and Powerpoint).
  • Demonstrates excellent verbal, written, and interpersonal communication skills across various team members and disciplines.
  • Demonstrates working knowledge and good proficiency in Project Management Information System such as e-Builder, Procore.
  • Executes all work with highest regard to quality and safety by ensuring compliance with GMPs, applicable EHS regulations, standard operating procedures, and industry practices.
  • Training and direct experience in cGxP quality compliance such as identifying, writing and processing deviations, investigations, CAPAs using electronic document management systems.
  • Project Management skills including the development and management of work breakdown structures, schedules, budgets, risk identification and management, change management.
  • Understanding of city permitting process, building codes and OSHA regulations as it relates to engineering and facilities construction.
  • Ability to read and understand engineering specifications, Architectural, MEP and P&ID Drawings.
  • Understand, interpret, and apply laws, rules, regulations, policies, procedures, contracts, budgets, and labor management agreements.
  • Proficient with construction terminology and legal content of construction contracts, documents and logistics.
  • In-depth knowledge of construction project delivery approach (e.g., design-bid-build, design-assist, design-build, IPD) and types of contracts (e.g., GMP, Lump Sum, Incentive).


RESPONSIBLITIES:
  • Provides cGXP expertise and guidance in planning, construction, start-up and commissioning, and validation of cGXP projects.
  • Posses' knowledge and complies with all safety regulations, FDA, and cGXP requirements to ensure compliance.
  • Manages moderately complex department/cross-functional specific programs and/or initiatives.
  • Manages moderately complex project/initiative communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
  • Provides Project Management support for programs/projects/initiatives; attends sub-team meetings; organizes ad hoc working groups as needed.
  • Provides leadership to the team and functional areas to anticipate and identify project issues which pose a challenge to achieving strategic goals; proposes and implements plans to resolve such issues and execute corrective actions.
  • Identifies and manages critical path activities and resources.
  • May manage the work of less experienced colleagues, contractors, vendors and/or third parties.
  • Works in partnership with Project Sponsor/Lead and stakeholders to ensure timely, efficient, and effective meetings and progress on activities between meetings.
  • Works in partnership with Project Sponsor/Lead to develop, gain approval, and execute on strategy.
  • Co-chairs project meetings and coordinates moderately complex team operations and communications.
  • Manages preparation of high-quality documents for review by internal committees and external stakeholders in partnership with senior Project participants. May author documents and/or procedures for leadership teams.
  • Tracks and prepares project information and activities, including minutes, timelines, budgets, action items and function-specific deliverables. Ensures integration of project timing, scope, and resources.
  • Represents Project Team to functional area leadership and/or steering committees for strategic decisions.
  • Recognized as a functional area expert for specific project and/or programs.
  • May represent Gilead at external professional meetings or discussions with industry trade groups.
  • May develop and implement continuous improvement and optimization initiatives across the department.
  • Ensures project work complies with established practices, policies, and processes and any regulatory or other requirements.
  • May have one or more direct reports.


Basic Qualifications:

High School Degree and Eleven Year's Experience

OR

Associates Degree and Nine Years Exprience

OR

Bachelor's Degree and Seven Years' Experience

OR

Masters' Degree and Five Years' Experience

Preferred Qualifications:
  • BA/ BS in Engineering with 7+ years' relevant project management or experience in the biopharma industry, or 5+ years' relevant experience with an advanced degree.
  • A degree in Mechanical, Electrical, Chemical or Structural Engineering is preferred.
  • Experience must include 1+ years leading cross-functional project management activities within the biopharma industry; building, managing, and articulating comprehensive, complex, cross-functional plans.
  • Experience in successfully managing multiple projects simultaneously.
  • PMP (Project Management Professional) or other PM certification or equivalent is a plus.


Job Requirements:
  • Job Type: Full-time, on site 100% of the time (not remote work)
  • Physical requirements: Candidate must be comfortable working in construction sites wearing required PPE and must be able to lift up to 25 lbs. Must be able to climb ladders or stairs at construction sites. Must be able to visually inspect construction job site routinely and compare against target milestones.
  • Travel - travel may be required on an as-needed basis


People Leader Accountabilities
  • Create Inclusion - knowing the business value of diverse teams, modeling Inclusion, and embedding the value of diversity in the way they manage their teams.
  • Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
  • Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.


The salary range for this position is: $154,020.00 - $199,320.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 ApplicantAccommodations@gilead.com for assistance.

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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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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