ZipRecruiter

Log In

1

Fda Reviewer Jobs (NOW HIRING)

Hitachi

FDA Validation Engineer

Nashville, TN · On-site

Join us as an FDA Validation Engineer. Location type: This is an onsite position based in Nashville ... Review qualification/requalification packages for completeness and accuracy, sound rationale ...

Captek International

QA PBR Reviewer

Vista, CA · On-site

$21 - $23/hr

Reviews and reconciles, production batch records (PBRs) per Standard Operating Procedures (SOPs ... Working knowledge of ISO, cGMP, or FDA regulations as it pertains to document control. * General ...

GDIT

Serve as the primary contact with the FDA; review, analyze, and respond to FDA communications and meetings by the regulatory deadline * Lead the development, organization, and structure of regulatory ...

next page

Showing results 1-20

All JobsFda Reviewer Jobs

Fda Reviewer information

See salary details

$10

$29

$48

How much do fda reviewer jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for fda reviewer in the United States is $29.88, according to ZipRecruiter salary data. Most workers in this role earn between $22.60 and $36.54 per hour, depending on experience, location, and employer.

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

To thrive as an FDA Reviewer, you need a strong background in scientific research, regulatory affairs, and a relevant advanced degree such as pharmacy, biology, chemistry, or medicine. Familiarity with regulatory submission systems, data analysis tools, and knowledge of FDA guidelines and Good Clinical Practice (GCP) is critical. Attention to detail, effective communication, and critical thinking are essential soft skills for evaluating complex data and collaborating with stakeholders. These skills ensure accurate and thorough assessments of products, supporting public health and regulatory compliance.

What are FDA Reviewers?

FDA Reviewers are professionals who evaluate and assess applications for the approval of drugs, medical devices, biologics, and other products regulated by the U.S. Food and Drug Administration (FDA). They review scientific data, clinical trial results, and manufacturing information to ensure the safety, efficacy, and quality of products before they reach the market. FDA Reviewers work within specialized teams and often collaborate with scientists, physicians, and regulatory experts. Their work helps protect public health by ensuring that only safe and effective products are available to consumers.

What are some common challenges faced by FDA Reviewers during the product evaluation process?

FDA Reviewers often face tight deadlines and must carefully balance thorough scientific evaluation with regulatory timelines. Reviewing large volumes of complex data, ensuring compliance with evolving regulations, and collaborating with multidisciplinary teams can be demanding. Additionally, reviewers must stay updated on new scientific developments and technologies, which requires continual learning and adaptability. These challenges make strong organizational skills and effective communication crucial for success in this role.

What is the difference between Fda Reviewer vs Fda Investigator?

AspectFda ReviewerFda Investigator
Primary RoleReview and evaluate regulatory submissions for safety, efficacy, and compliance of medical productsConduct inspections and investigations to ensure compliance with FDA regulations
Work EnvironmentOffice-based, reviewing documents and dataFieldwork, inspecting facilities and conducting interviews
Required CredentialsTypically a background in life sciences, healthcare, or related fields; often requires a degree and regulatory knowledgeSimilar credentials; often a degree in sciences, with training in inspection procedures

While both roles work within the FDA and require scientific knowledge, Fda Reviewers focus on evaluating submissions for approval, whereas Fda Investigators conduct on-site inspections to verify compliance. Both positions are essential for ensuring the safety and efficacy of medical products, but they differ in daily tasks and work settings.

More about Fda Reviewer jobs
What cities are hiring for Fda Reviewer jobs? Cities with the most Fda Reviewer job openings:
What states have the most Fda Reviewer jobs? States with the most job openings for Fda Reviewer jobs include:
What job categories do people searching Fda Reviewer jobs look for? The top searched job categories for Fda Reviewer jobs are:
Fda Reviewer jobs near you
Infographic showing various Fda Reviewer job openings in the United States as of May 2026, with employment types broken down into 60% Full Time, 20% Part Time, and 20% Contract. Highlights an 100% In-person job distribution, with an average salary of $62,159 per year, or $29.9 per hour.
Director, Quality Compliance (DEA & FDA)

Director, Quality Compliance (DEA & FDA)

Kelly Services

Greenville, SC

$180K - $220K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 6 days ago

Job description

Sr. Director of Quality Compliance

Full-Time | Senior Leadership

Location: Greenville, SC (Onsite Role)

Compensation: Approximately $180,000-$220,000 base salary + bonus potential

Position Summary

A growing pharmaceutical manufacturing organization is seeking a Sr. Director of Quality Compliance to lead enterprise-wide compliance strategy, governance, audit readiness, inspection management, escalation processes, and quality risk management activities. This individual will serve as a key member of the Quality Leadership team and will drive continuous improvement initiatives to ensure sustained compliance with cGMP, FDA, DEA, DSCSA, and international regulatory requirements.

This role will oversee quality compliance systems and inspection readiness programs while partnering cross-functionally with Quality, Manufacturing, Regulatory, Supply Chain, and Executive Leadership teams. The ideal candidate will bring deep expertise in pharmaceutical quality systems, regulatory inspections, auditing, and enterprise compliance strategy within GMP-regulated manufacturing environments.

Key Responsibilities

Quality Compliance & Regulatory Oversight

  • Develop and implement enterprise quality compliance strategies, programs, and policies
  • Ensure compliance with FDA, DEA, cGMP, ICH, DSCSA, and global regulatory requirements
  • Lead inspection readiness programs and provide on-site support during regulatory inspections
  • Serve as the primary escalation point for significant quality and compliance risks
  • Manage quality notification-to-management and escalation programs
  • Interpret evolving regulatory requirements and implement systemic compliance improvements

Audit & Inspection Management

  • Direct internal audit programs across manufacturing and quality operations
  • Lead and manage external audits conducted by FDA, DEA, notified bodies, clients, and global health authorities
  • Review audit observations and drive effective CAPA implementation
  • Maintain audit-ready quality systems and documentation practices
  • Track and trend quality indicators and compliance metrics

Quality Systems & Risk Management

  • Oversee core Quality Management System (QMS) processes including:
  • Change control
  • Deviations
  • CAPAs
  • Document management
  • Supplier quality
  • Escalation management
  • Analyze quality data and trends to identify systemic risks and improvement opportunities
  • Ensure effective statistical monitoring and reporting of quality compliance metrics
  • Support post-market surveillance and ongoing product quality monitoring activities

Leadership & Cross-Functional Collaboration

  • Lead and develop Quality Compliance teams and associated quality personnel
  • Partner with Manufacturing, Quality Control, Regulatory Affairs, and Executive Leadership to drive strategic quality initiatives
  • Foster a culture of compliance, accountability, and continuous improvement
  • Support implementation of quality-focused operational efficiencies and business improvements
  • Present quality compliance updates and risk assessments to senior leadership

Continuous Improvement & Strategy

  • Drive initiatives focused on improving inspection outcomes, audit performance, and overall quality culture
  • Lead implementation of systemic process improvements across manufacturing and quality operations
  • Evaluate and enhance quality systems effectiveness through analytics and risk management principles
  • Support modernization initiatives involving predictive analytics, technology platforms, and quality data visibility

Qualifications

Required Education & Experience

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related scientific discipline
  • 15+ years of progressive pharmaceutical quality experience within GMP-regulated manufacturing environments
  • Prior senior leadership experience in Quality Compliance, Quality Assurance, or Regulatory Compliance
  • Strong experience interacting directly with FDA and global regulatory agencies

Technical Expertise

  • Deep knowledge of:
  • cGMP regulations
  • FDA and global regulatory requirements
  • DEA compliance
  • Quality systems and auditing
  • Risk management principles
  • Pharmaceutical manufacturing operations
  • Experience supporting API, aseptic, sterile, or OTC manufacturing environments preferred
  • Strong understanding of:
  • Deviations
  • CAPAs
  • Change controls
  • Inspection readiness
  • Supplier quality management
  • Data integrity

Additional Information

  • Travel up to approximately 40% may be required
  • Relocation assistance may be available
  • Experience within pharmaceutical manufacturing, CDMO, or highly regulated GMP environments strongly preferred

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.