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Fda Project Jobs in Virginia (NOW HIRING)

Project Management Professional (PMP) | Project Management Institute (PMI) - Project Management ... This role is hybrid, requiring 3 days in office at the GDIT Gaithersburg office and FDA Silver ...

Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...

Ensure all projects comply with FDA, cGMP, EPA, safety, and internal standards. * Promote workplace safety and ensure safety requirements are integrated into all project scopes. * Resolve process and ...

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle Monitor and track project performance, proactively identifying risks and ...

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

ICF is seeking an experienced Project Manager / PMO Lead to support delivery of a complex federal ... Experience with federal IT programs in HHS, NIH, FDA, CMS, CDC, or other health-focused agencies

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Fda Project information

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.
What are popular job titles related to Fda Project jobs in Virginia? For Fda Project jobs in Virginia, the most frequently searched job titles are:
What cities in Virginia are hiring for Fda Project jobs? Cities in Virginia with the most Fda Project job openings:
Program Delivery Manager - FDA

Program Delivery Manager - FDA

GDIT

Falls Church, VA • Hybrid

$157K - $212K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 9 days ago


General Dynamics Information Technology rating

7.8

Company rating: 7.8 out of 10

Based on 63 frontline employees who took The Breakroom Quiz

74th of 210 rated it services


Job description

Type of Requisition:

Regular

Clearance Level Must Currently Possess:

None

Clearance Level Must Be Able to Obtain:

None

Public Trust/Other Required:

MBI (T2)

Job Family:

Program Delivery and Execution

Job Qualifications:

Skills:

Client Relationship Management, Delivery Management, Risk Control, Scaled Agile Framework (SAFe)

Certifications:

Project Management Professional (PMP) | Project Management Institute (PMI) - Project Management Institute (PMI)

Experience:

10 + years of related experience

US Citizenship Required:

No

Job Description:

General Dynamics Information Technology (GDIT) is hiring a Program Delivery Manager to lead delivery execution for a major FDA modernization program. This role is key to ensuring highquality, on time delivery in a complex, fastmoving, Agile environment.

The Program Delivery Manager will provide handson leadership across multiple technical and functional teams, ensuring alignment with program priorities, managing dependencies, and driving predictable, efficient execution. The role requires close coordination with the Senior Program Manager, government stakeholders, and enduser communities to ensure delivery meets mission needs.

Responsibilities include overseeing resources across development releases, O&M, Help Desk operations, and emerging AI initiatives; identifying and escalating risks; and maintaining transparency and stakeholder alignment. This is a highimpact role for a leader skilled at driving consistent delivery, elevating team performance, and ensuring solutions meet quality and mission standards.

**This role is hybrid, requiring 3 days in office at the GDIT Gaithersburg office and FDA Silver Spring campus.***

This role will require you to obtain and maintain a Public Trust and will require you to provide onsite fingerprinting at a designated facility. This investigation may review personal and criminal behavior, financial conduct, foreign influence, as well as other adjudications.

Responsibilities:

  • Drive disciplined delivery execution through clear expectations, proactive issue resolution, and strong quality oversight.

  • Align delivery decisions with mission needs, business processes, and real program outcomes.

  • Maintain tight crossteam coordination and validate deliverables throughout the SDLC.

  • Communicate accomplishments, risks, dependencies, and impacts clearly to stakeholders.

  • Build strong client engagement to understand priorities and maintain alignment with evolving needs.

  • Break down complex initiatives into scalable, structured workstreams with defined scope and sequencing.

  • Assess and quantify workstream complexity, identifying scale drivers and related risks.

  • Integrate new workstreams into governance and Agile operating rhythms without disrupting stability.

  • Apply practical Agile methods to maintain predictability, address bottlenecks, and drive modernization and automation.

  • Produce clear internal reports, consolidate key metrics, support audits, escalate major risks, and keep leadership aligned.

Required Skills and Experience:

  • Bachelor's degree with 12+ years of experience (or equivalent combination of education and experience)

  • Current or recent experience leading enterprise program, preferably at the HHS or FDA

  • Experience managing multi-system projects and working with cross-functional project teams in a matrixed environment

  • People Management experience; career counselling and mentorship skills

  • Experience in managing projects with Agile values, principles, processes, and methods such as iterative and incremental development, burn down, continuous integration, and test-driven

  • Demonstrated AI mindset, including ability to leverage AI-driven insights, adapt data informed decision-making, and guide teams in responsible use of automation, analytics, and emerging technologies.

  • Must be able to obtain a Public Trust with 3 out of the last 5 years of residency in the US

Desired Skills and Experience:

  • Experience managing large-scale and complex enterprise transformation programs

  • Experience with SAS products like Appian and Pega

  • Experience working in a SAFe Agile Environment

  • A passion for the mission the project is supporting

  • Active PMI PMP certification

#GDITFedHealthJobs

The likely salary range for this position is $157,250 - $212,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Scheduled Weekly Hours:

40

Travel Required:

50-75%

Telecommuting Options:

Hybrid

Work Location:

USA MD Gaithersburg

Additional Work Locations:

USA VA Falls Church

Total Rewards at GDIT:

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

Our Identity Verification Process:

As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during virtual interviews. We reserve the right to take your picture to verify your identity and prevent fraud. By proceeding, you authorize the collection, processing, and use of your biometric data for identity verification and security purposes.

About Our Work:

We are GDIT. A global technology and professional services company that delivers technology solutions and mission services to every major agency across the U.S. government, defense and intelligence community. Our 26,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50+ countries worldwide, offering leading mission-ready capabilities in AI, cloud, cyber and software development.Join our Talent Community to stay up to date on our career opportunities and events at

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Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

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About General Dynamics Information Technology

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GDIT is a global technology and professional services company that delivers technology solutions and mission services to every major agency across the U.S. government, defense, and intelligence community. Its 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. The company operates across 50+ countries worldwide, offering leading capabilities in digital modernization, AI/ML, cloud, cyber, and application development.

Industry

It services

Company size

10,000+ Employees

Headquarters location

Falls Church, VA, US