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Fda Program Analyst Jobs (NOW HIRING)

GDIT

Program Manager

College Park, MD · Hybrid

$176K - $239K/yr

This role translates FDA scientific and mission priorities into computing strategies, oversees ... analysis. * Lead strategic modernization initiatives such as HPC expansion, hybrid cloud ...

GDIT

Program Manager

Gaithersburg, MD · Hybrid

$176K - $239K/yr

This role translates FDA scientific and mission priorities into computing strategies, oversees ... analysis. * Lead strategic modernization initiatives such as HPC expansion, hybrid cloud ...

GDIT

Functional Project Manager - FDA

Gaithersburg, MD · Hybrid

$131K - $178K/yr

As the Functional Project Manager , you will be responsible for setting program directions for a ... Bachelor's degree and 8+ years of business analysis experience in the IT industry, with recent ...

Cal-Maine Foods, Inc.

Compliance Manager

Tooele, UT · On-site

Ensures animal welfare and FDA program compliance, including training and reporting. * Ensures ... Ability to read, analyze, and interpret general business periodicals, professional journals ...

Cal-Maine Foods, Inc.

Compliance Manager

Tooele, UT · On-site

Ensures animal welfare and FDA program compliance, including training and reporting. * Ensures ... Ability to read, analyze, and interpret general business periodicals, professional journals ...

Cal-Maine Foods, Inc.

Compliance Manager

Tooele, UT · On-site

Ensures animal welfare and FDA program compliance, including training and reporting. * Ensures ... Ability to read, analyze, and interpret general business periodicals, professional journals ...

LabAnswer

LIMS SME/Business Analyst

Atlanta, GA · Remote

... FDA leadership to identify data needs for LIMS and/or ELN functionality. Provide strategic ... Defines the problem, and develops system requirements and program specifications from which ...

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Fda Program Analyst information

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$37K

$89.2K

$131.5K

How much do fda program analyst jobs pay per year?

As of Sep 13, 2026, the average yearly pay for fda program analyst in the United States is $89,153.00, according to ZipRecruiter salary data. Most workers in this role earn between $69,000.00 and $116,000.00 per year, depending on experience, location, and employer.

Is a FDA Program Analyst a role in demand?

FDA Program Analyst roles are in demand due to ongoing regulatory needs in the healthcare and food industries. These positions often require knowledge of regulatory policies, data analysis skills, and familiarity with FDA systems, making them valuable in government and private sectors focused on compliance and safety.

What are popular job titles related to Fda Program Analyst jobs?

For Fda Program Analyst jobs, the most frequently searched job titles are:

Infographic showing various Fda Program Analyst job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 74% Full Time, 20% Part Time, and 4% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $89,153 per year, or $42.9 per hour.

Senior CAPA FDA Lead

Bothell, WA • On-site

Accord Technologies Inc.
IT Services • 51 - 200 employees
Learn more about Accord Technologies Inc.external

Contractor

Re-posted 27 days ago

Job description

Position : Senior CAPA FDA Lead
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C

 
 
Job Description

Key Responsibilities
  • Lead FDA audit and inspection readiness activities across the business.
  • Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
  • Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C Contract

Job Title
Senior CAPA FDA Lead
Job Description
Key Responsibilities
  • Lead FDA audit and inspection readiness activities across the business.
  • Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
  • Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication