1

Manager Fda Consulting Jobs (NOW HIRING)

E-logic is seeking a veteran Project Manager (PM) to lead a mission-critical federal contract ... FDA). Hiring is contingent upon the selection of the consultant. Selected candidates will be ...

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and ... FDA General Manager / Director Key Responsibilities Team Leadership & Supervision * Supervise and ...

EAS Consulting Group - A regulatory consulting firm offering expert guidance, training, and ... FDA General Manager / Director Key Responsibilities Team Leadership & Supervision * Supervise and ...

ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science ... Support ongoing system lifecycle management: periodic reviews, requalification, and change control.

next page

Showing results 1-20

Manager Fda Consulting information

What are the key skills and qualifications needed to thrive as a Manager in FDA Consulting, and why are they important?

To thrive as a Manager in FDA Consulting, you need a deep understanding of FDA regulations, compliance strategies, and industry best practices, typically supported by a relevant degree and experience in regulatory affairs. Familiarity with regulatory submission systems like eCTD, and certifications such as RAC (Regulatory Affairs Certification), are commonly required. Strong leadership, problem-solving abilities, and excellent communication skills set top performers apart in this role. These competencies ensure clients receive effective guidance through complex regulatory processes, minimizing compliance risks and expediting product approvals.

What does a Manager in FDA consulting do?

A Manager in FDA consulting oversees projects and teams that help clients navigate the regulatory requirements set by the U.S. Food and Drug Administration (FDA). Their responsibilities include advising companies on compliance, preparing submissions, and developing strategies to obtain FDA approvals for products such as drugs, medical devices, and food items. They also ensure clients are up-to-date with changing regulations and help resolve any regulatory issues that may arise. This role requires strong project management skills, deep regulatory knowledge, and the ability to communicate complex requirements to clients.

What is the difference between Manager Fda Consulting vs Regulatory Affairs Specialist?

AspectManager Fda ConsultingRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's or master's in life sciences, with experience in FDA regulationsUsually holds a bachelor's degree in life sciences or related field, with certification preferred
Work EnvironmentConsulting firms, client sites, or remote; project-based workIn-house or pharmaceutical/medical device companies; regulatory departments
Industry UsageCommonly employed in consulting firms advising multiple clientsPrimarily employed within companies managing regulatory submissions

While both roles require knowledge of FDA regulations, a Manager Fda Consulting typically leads consulting projects and advises clients, whereas a Regulatory Affairs Specialist manages regulatory submissions within a company. The roles differ mainly in scope, environment, and responsibilities, but share core regulatory knowledge.

How does a Manager in FDA Consulting typically collaborate with cross-functional teams to ensure regulatory compliance for clients?

As a Manager in FDA Consulting, you'll frequently work alongside experts from regulatory affairs, quality assurance, clinical research, and product development to guide clients through complex compliance challenges. This often involves facilitating meetings, interpreting FDA guidelines, and coordinating the preparation of submission documents. Strong communication skills are essential, as you'll translate regulatory requirements into actionable strategies for diverse teams. Collaboration is key to ensuring all stakeholders are aligned and that client deliverables meet both regulatory and business objectives.
More about Manager Fda Consulting jobs
What cities are hiring for Manager Fda Consulting jobs? Cities with the most Manager Fda Consulting job openings:
What are the most commonly searched types of Fda Consulting jobs? The most popular types of Fda Consulting jobs are:
What states have the most Manager Fda Consulting jobs? States with the most job openings for Manager Fda Consulting jobs include:
What job categories do people searching Manager Fda Consulting jobs look for? The top searched job categories for Manager Fda Consulting jobs are:
Infographic showing various Manager Fda Consulting job openings in the United States as of July 2026, with employment types broken down into 93% Full Time, 4% Part Time, and 3% Contract. Highlights an 84% Physical, 4% Hybrid, and 12% Remote job distribution.
Test Engineer II (ITS16) Custom Computer Programming Services

Test Engineer II (ITS16) Custom Computer Programming Services

ProSidian Consulting

Silver Spring, MD • On-site

$114K - $135K/yr

Full-time

Posted 16 days ago


Job description

Company Description
  • ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices. ProSidian services focus on the broad spectrum of Enterprise Service Solutions for Risk Management | Compliance | Business Process | IT Effectiveness | Engineering | Environmental | Sustainability | and Human Capital. We help forward-thinking clients solve problems and improve operations.
  • Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies.  Our solution-centric services are deployed across the enterprise, target drivers of economic profit (growth, margin, and efficiency), and are aligned at the intersections of assets, processes, policies, and people delivering value.
  • ProSidian clients represent a broad spectrum of industries including but not limited to Aerospace And Telecommunications | Consumer Products, Services, And Retail | Development And Sustainability | DOD/Military | Energy, Resources, & Industrials | Financial Services | Government & Public Services | Information Technology, Media, And Telecommunications | Life Sciences & Health Care | Manufacturing And Operations | Nuclear and Environmental | Professional Services |, etc.  Learn More About ProSidian Consulting at www.ProSidian.com.
Job Description
  • Provide The Center for Food Safety and Applied Nutrition (CFSAN) IT System Lifecycle Development and Management Support Services on behalf of the Food and Drug Association (FDA). The FDA is seeking Small Business (SB) sources to determine the availability and capability of small business manufacturers or small businesses capable of IT System Lifecycle Development and Management Support Services.
  • The FDA | CFSAN is in need of project management services. The Single Award Blanket Purchase Agreement (BPA) will be awarded by the FDA contracting manager.  The Center for Food Safety and Applied Nutrition (CFSAN) is the branch of the United States Food and Drug Administration that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products. 
  • The scope of this contract is to provide the full range of technical and management services necessary to develop, maintain, and enhance CFSAN systems. The general requirements include providing Custom Computer Programming Services (NAICS 541511) to the FDA and CFSAN; and to maintain, support, and evolve code, scripts, views, triggers, jobs, designs, documentation, reports, and templates. 
  • There is also a need to establish an ordering vehicle that develops and maintains existing and future Computer to Plate (CTP) systems, which will process structured and unstructured data. The FDA expects between 2-5 new applications/systems to be added to the BPA per year over the duration of this contract. The ProSidian Engagement Team shall provide training services to CFSAN stakeholders for existing applications, application changes, or newly-developed applications.  CFSAN will issue individual Task Orders for the Contractor to provide IT Lifecycle Support for the CFSAN IT portfolio of systems as needed. Representative tasks to be performed. 

THE BLANKET PURCHASE AGREEMENT IS DIVIDED INTO THE FOLLOWING (9) TASK AREAS: 

  • Task 1: Project Management:  Task Order level project management to establish control, management, monitoring and notification mechanisms to ensure the individual task orders stay on track to meet the important milestones and performance measures within the awarded task. | DOCUMENTATION:  The Contractor shall use FDA supplied templates which will be provided on each individual Task Order as applicable. If an FDA template does not exist, the Contractor may be tasked with drafting a template for approval by the COR.
  • Task 2: O&M and DME Architecture Support Services:  The Contractor shall provide the full range of architecture support services in order to formulate the integrated, end-to-end automated systems that provide enhanced IT capabilities necessary to support CFSAN business and mission processes. The goal is a stable evolutionary progression from an organization's current state to its envisioned future state by identifying tools and technologies that work together to satisfy the needs or changing business needs of the CFSAN users.
  • Task 3: Development, Modernization, and Major Enhancement: The Contractor shall provide the complete range of system development lifecycle support services necessary to develop and enhance CFSAN IT systems and tools as well as their external interfaces to FDA Enterprise and Center Systems and applications. Tasks may encompass the complete lifecycle of activities required for database, application and tool development including, but not limited to requirements elicitation, analysis and validation; system design; code generation; testing; deployment; and documentation.  The Contractor shall also develop, support and evolve designs, customizations and process automation such as interfaces, templates, scripts, workflows, interfaces to permit reviewer access to analytics/tools, and reports. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements.
  • Task 4: Systems Integration and Engineering Services:  The Contractor shall support CFSAN with integration services. The Contractor shall focus on the development and deployment of integrated information systems that reflect the introduction of a Service Oriented Architecture (SOA) orientation and, moreover, places an emphasis on the recommended acquisition and re-use of existing components-be they FDA components, HHS components, or components acquired from any other source. 
  • Task 5: Data Migration and Management Support:  The Contractor shall provide data management support for activities related to the development and execution of data architectures, data policies, practices, and procedures that properly manage the full data lifecycle needs of CFSAN. Task #6 - Operations and Maintenance (O&M) and Support Services
  • Task 6: Operations and Maintenance (O&M) and Support Services:  The Contractor shall provide the complete range of operations and maintenance support services necessary to maintain CFSAN IT systems. The Contractor shall be responsible for maintaining the "lights on" availability, reliability, and security of the CFSAN IT portfolio through the full range of O&M services. The Contractor shall maintain, support, and evolve code, scripts, views, triggers, jobs, designs, documentation, reports, and templates. The Contractor shall analyze and report on the impact of infrastructure, software upgrades, capacity, and all changes to the technical environment. These day-to-day operations, maintenance, and help desk support ensures that the systems perform their intended functions.
  • Task 7: System and Data Disposition:  The Contractor shall identify, recommend and implement the retirement and consolidation of systems, components, technologies, tools and data when they meet the appropriate disposition stage of the lifecycle as defined in the EPLC. 
  • Task 8: Training Support for O&M and DME:  The Contractor shall provide training services to CFSAN stakeholders for existing applications, application changes, or newly developed applications. The Contractor shall assess the level of capability of the users and the need for training. The Contractor shall prepare a training plan, the training materials, and arrange and conduct training sessions. The training plan and materials shall be provided to the COR for review and approval prior to training.
  • Task 9: Transition Activities:  The Contractor shall provide the transition-in and transition-out of activities to develop, operate, and manage the CFSAN IT portfolio. It is the responsibility of both the incoming Contractor and outgoing Contractor to ensure a smooth transition, with minimal disruption to services and support for users. The purpose of the transition is to transfer expert knowledge, data, and artifacts that are used to support applications from the incumbent Contractor to the successor Contractor efficiently.

*** Enterprise Performance Lifecycle (EPLC) Agile Methodology:  The Food and Drug Administration maintains a project management methodology framework that incorporates best government and commercial practices through a consistent and repeatable process, and provides a standard structure for planning, managing and overseeing IT projects over their entire life cycle.  The HHS Enterprise Performance Life Cycle (EPLC) framework provides that methodology for HHS OPDIVs including FDA.

Qualifications

TEAM PROSIDIAN PERSONNEL SHALL HAVE EXPERIENCE IN THE FOLLOWING:

  • Expertise and experience in designing, developing, implementing, communicating, administering and evaluating human resources programs, with emphasis in compensation and classification in large (i.e., over 4,000 employees) geographically dispersed organizations with a technical, multi-faceted mission of national scope.
  • Demonstrated successful experience in designing and implementing innovative private and public sector compensation and pay for performance programs, and/or expertise in a unionized environment.
  • Experience in job analysis and evaluation, with expertise in making accurate Fair Labor Standards Act (FLSA) exemption determinations, and demonstrated ability to successfully defend those decisions to employees, management, and/or outside parties.
  • Expertise in state-of-the art compensation, pay for performance, and awards programs, with the ability to tailor such programs to a public-sector regulatory/operational organization.
  • Knowledge of existing laws and regulations pertaining to the federal compensation, classification, performance, and recognition programs, and to the federal financial regulatory agencies. 


TEST ENGINEER II - ENGAGEMENT TEAM MEMBER QUALIFICATIONS:

  • Evaluate, recommend and implement test tools and strategies in various technical environments. Experience in performance testing, system testing, 508 testing, end user testing, and regression testing. Write and modifies test scripts. Reports test results
Additional Information

As a condition of employment, all employees are required to fulfill all requirements of the roles for which they are employed; establish, manage, pursue, and fulfill annual goals and objectives with Documented Goals for each of the firm's Eight ProSidian Global Competencies [1 - Personal Effectiveness | 2 - Continuous Learning | 3 - Leadership | 4 - Client Service | 5 - Business Management | 6 - Business Development | 7 - Technical Expertise | 8 - Innovation & Knowledge Sharing (Thought Leadership)]; and to support all business development and other efforts on behalf of ProSidian Consulting.

CORE COMPETENCIES

  • Teamwork - ability to foster teamwork collaboratively as a participant and effectively as a team leader
  • Leadership - the ability to guide and lead colleagues on projects and initiatives
  • Business Acumen - understanding and insight into how organizations perform, including business processes, data, systems, and people
  • Communication - ability to effectively communicate to stakeholders of all levels orally and in writing
  • Motivation - persistent in pursuit of quality and optimal client and company solutions
  • Agility - ability to quickly understand and transition between different projects, concepts, initiatives, or workstreams
  • Judgment - exercises prudence and insight in the decision-making process while being mindful of other stakeholders and long-term ramifications
  • Organization - the ability to manage projects and actions and prioritize tasks

------------ ------------ ------------

OTHER REQUIREMENTS

  • Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint, and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
  • Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint, and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
  • Commitment - to work with smart, interesting people with diverse backgrounds to solve the most significant challenges across private, public, and social sectors
  • Curiosity - the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
  • Humility - exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
  • Willingness - to constantly learn, share, and grow and to view the world as their classroom

------------ ------------ ------------

BENEFITS AND HIGHLIGHTS

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That's why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently includes the following for Full-Time Employees:

  • Competitive Compensation: The pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. The Company contributes a fixed dollar amount each mont...

ProSidian Consulting logo

About ProSidian Consulting

Sourced by ZipRecruiter

ProSidian is a management and operations consulting firm with a reputation for its strong national practice spanning six solution areas including Risk Management, Energy & Sustainability, Compliance, Business Process, IT Effectiveness, and Talent Management. We help clients improve their operations. Linking strategy to execution, ProSidian assists client leaders in maximizing company return on investment capital through design and execution of operations core to delivering value to customers. Visit www.ProSidian.com or follow the company on Twitter at www.twitter.com/ProSidianfor more information.

Industry

Business schools and computer and management training

Company size

11 - 50 Employees

Headquarters location

Charlotte, NC, US

Year founded

2004

Social media