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Manager Fda Consulting Jobs in Park Ridge, IL (NOW HIRING)

cGMP Consulting

Autoclave Validation Engineer

North Chicago, IL · On-site

$75K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and ... Perform activities related to scoping, executing, and managing engineering projects involving ...

cGMP Consulting

Utility Validation Engineer

Melrose Park, IL · On-site

$75K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

About Us At cGMP Consulting, we specialize in providing expert validation, qualification, and ... Manage multiple qualification activities while providing deliverable updates and modifications to ...

New

Compsciprep LLC

CSV Validation Consultant

Chicago, IL · On-site

Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations * Experience in IT Compliance ... Knowledge of CTMS (Clinical Trial Management System) * Preparation and review of validation ...

Codal

Senior Product Manager - Digital Transformation

Chicago, IL · On-site

$130K - $172K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Build strong, consultative relationships with client stakeholders. * Partner with Codal's account ... Familiarity with regulated environments (HIPAA, FDA, etc.). * CSPO or similar agile product ...

Saxon Global

IT Compliance

Lake Forest, IL · On-site

$93K - $93K/yr

... , and engineering solution services from past 16 years. Saxon global specializes in Business ... Partner with the IT Compliance managers and director to enhance the IT control environment based on ...

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Manager Fda Consulting information

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.

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.

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 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.

What job categories do people searching Manager Fda Consulting jobs in Park Ridge, IL look for?

The top searched job categories for Manager Fda Consulting jobs in Park Ridge, IL are:

What cities near Park Ridge, IL are hiring for Manager Fda Consulting jobs?

Cities near Park Ridge, IL with the most Manager Fda Consulting job openings:

Manager Fda Consulting jobs near you
Infographic showing various Manager Fda Consulting job openings in Park Ridge, IL as of August 2026, with employment types broken down into 81% Full Time, 17% Part Time, 1% Contract, and 1% Nights. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution.

Cleaning Validation Subject Matter Expert

cGMP Consulting

North Chicago, IL • On-site

$120K - $160K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted yesterday

New

Job description

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.
cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI. 

Position Summary

cGMP Consulting is seeking an experienced and driven individual to lead and manage cleaning validation activities, prepare and execute protocols, and act as SME regarding cleaning development and validation. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment. 

The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols. This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards. 

Responsibilities 

The essential functions include, but are not limited to the following: 

  • Design and develop cleaning procedures for new product and manufacturing equipment.
  • Provide technical support to cleaning activities associated with the manufacturing process.
  • Lead the cleaning validation program and activities.
  • Knowledge of cleaning agents and establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suite areas.
  • Design and support implementation of cleaning strategies for product transfer projects and product development projects.
  • Investigate and conduct troubleshooting or root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under developed cleaning procedures.
  • Lead enhancement of cleaning practices and review and approve work instructions.
  • Support the periodic review of cleaning validation studies.
  • Perform successful resolution of incidents and deviations related to cleaning activities.
  • Issue change controls required for implementation of cleaning procedure changes.

Requirements 

  • Minimum Bachelors’ degree in Engineering, Science, or a related field of study. 
  • 4+ years’ experience in a GMP manufacturing environment, including cleaning validation. Must be familiar with regulatory (FDA) requirements. 
  • Expertise in multiple areas: cleaning validation, continuous process improvement, and/or qualification of aseptic filling or formulation equipment/processes. 
  • Advanced critical thinking and technical writing skills. 
  • Strong organizational, communication, and interpersonal skills. 

Compensation and Benefits 

  • Expected pay range per year: $120,000-$160,000 USD 
  • Expected benefits include: Medical, Dental, Vision, PTO, 401K 

Disclaimer 

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

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