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Fda Inspector Jobs in Raleigh, NC (NOW HIRING)

Revlon Corporate

Director, Quality Control

Oxford, NC · On-site

... cGMP, FDA expectations, laboratory investigations, data integrity, analytical method validation, stability, and laboratory equipment systems. • Experience supporting regulatory inspections ...

Indivior PLC

Director, Site Quality - Raleigh

Raleigh, NC · On-site

$140 - $190/hr

Act as the primary site representative for FDA and global Health Authority inspections, committing the organization to remediation strategies and owning critical compliance outcomes. * Provide ...

Humacyte, Inc.

Head of Pharmacovigilance

Durham, NC · On-site

$260 - $360/hr

Ensure that company is always GVP inspection ready from FDA and other Global Health Authorities * Ensure compliance of the PV system in collaboration with cross functional stakeholders. * Oversee ...

Aerogen

Senior Director of Quality

Morrisville, NC · On-site

$120 - $160/hr

... with FDA drugs, biologics, and combination product regulations, with awareness of ISO 13485. This ... Coordinate and participate in external audits and inspections, ensuring readiness and effective ...

Guerbet

QC Chemistry Lead

Raleigh, NC · On-site

$80 - $100/hr

Lead audits and inspections, ensuring readiness for regulatory reviews. * Provide training and ... Strong understanding of cGMP, FDA, ICH, and USP guidelines. * Knowledge of industry regulations and ...

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Fda Inspector information

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How much do fda inspector jobs pay per year?

As of Sep 7, 2026, the average yearly pay for fda inspector in Raleigh, NC is $53,405.00, according to ZipRecruiter salary data. Most workers in this role earn between $37,400.00 and $61,700.00 per year, depending on experience, location, and employer.

What does an FDA inspector do?

An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.

What skills and qualifications are needed to be an FDA inspector?

To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.

What types of facilities or products do FDA inspectors review, and what does a typical inspection process involve?

FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. They must pass a written exam and a background check, and often undergo specialized training at the FDA's training center. Certification or licensing is not required but can enhance prospects in the field.

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Fda Inspector jobs near you
Infographic showing various Fda Inspector job openings in Raleigh, NC as of August 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 100% In-person job distribution, with an average salary of $53,405 per year, or $25.7 per hour.

Director, Global Sterility Assurance Team Lead

Novartis

Durham, NC

Full-time

Medical, Retirement, PTO

Re-posted 29 days ago

Key responsibilities

  • Lead a team of experts in aseptic processing across manufacturing sites and ensure compliance with FDA and other health authority inspections.

  • Support and oversee the implementation of projects related to GMP updates, aseptic process optimization, and site readiness for inspections.

  • Own and monitor sterility assurance activities, develop improvement plans, and build aseptic governance and training programs.

Novartis rating

7.8

Company rating: 7.8 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

50th of 86 rated pharmaceutical

Job description

Job Description Summary

As Director, Global Sterility Assurance Team Lead you will:
• Lead a team (4-6 direct reports, 20-30 indirect) of Key functional Expert for Aseptic processing within the Novartis manufacturing network (includes Large Molecules and Advance therapies and third parties producing for Novartis).
• Ensures and verifies that all actions related to FDA and other health authority inspections are understood and implemented by the sites in the platform, avoiding re-occurrence of 483’s and Warning Letters.
• Assure that key projects are implemented in the manufacturing sites as per committed plan to FDA and other health authorities
• Ensure implementation of changes to support GMP updates (i.e. Annex 1) within all the sites in scope in order to assure ongoing compliance for the upcoming years. In this regard supports the gap assessment process and respective remediation and action tracking.
• Liaise with TechOps to ensure implementation, follow up and completeness of all related Quality/ Compliance programs, documentation and Quality reporting of Aseptic related projects / metrics.
• Ensure adequate Health Authority Inspection preparation of the Sites in scope and successful inspection outcomes. Interactions with sites mainly require interpretation of complex information and persuasion both internally with other areas of the business and the site leadership team and externally.


Job Description

Major Accountabilities:

  • Overall team leader that has the responsibility of 4-6 individual contributors hosted in US, Spain and Austria, plus 20-30 indirect reports located within the manufacturing sites performing sterile operations.
  • Lead cross site/platform and network projects and harmonization initiatives as assigned
  • Provide expert advice and appropriate technical support to ensure site readiness for Health Authority and GGA inspections by supporting sites in their preparation, up to and including hands on preparation of materials (i.e. storyboards for complex cases, etc.)
  • Primary Responsible for optimization of aseptic processes (as e.g. cleaning and disinfection programs, microbiological monitoring and sterilization techniques) between sites and platforms within the Novartis manufacturing network
  • Support escalations for specific topics (i.e. Microbial contaminations, sterility issues, etc.) with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.e. QA operations, QA compliance lead, QC/AS&T lead)
  • Own, Monitor and act as Primary contact for the sterility assurance from the sites and define improvement plans as appropriate.
  • Build fit for purpose aseptic governance and training program in collaboration with engineering and MS&T to support sites in development, training and understanding of aseptic topics
  • Provides input for the selection, training, people development and performance evaluation, development planning and participating in recruiting process of the Aseptic experts within the manufacturing sites / global functions.

Obligatory requirements:

  • Education: Graduate in Chemistry, Pharmacy, Microbiology or another related science; desirable: Ph.D. in science or related discipline
  • 12 - 15 years experience in management and leadership roles in the pharmaceutical industry, preferably in a FDA-regulated environment and in QA Operations & Compliance of a strategic Site or a global role. Pharma production experience indispensable. Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
  • Deep understanding of microbiology and aseptic processes
  • Solid People Management / Communication skills (To explain difficult business processes and related GMP-requirements to a community of very diversely oriented and educated people from a multitude of different units.
  • Excellent Project Management skills, especially with crossfunctional projects.
  • Fluent English written and spoken.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


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