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Gmp Consultant Jobs (NOW HIRING)

Automated Systems, Inc.

GMP Technical Writer

Madison, WI · On-site

$50 - $70/hr

GMP Technical Writer Contract: 6+ months with strong potential for contract-to-hire Location ... Company Description We are a dynamic, project oriented consulting company offering individuals a ...

Eliquent Life Sciences, Inc

Consultant 1

Montrose, CA · On-site

Execute validation testing and document results in compliance with GMP/GLP standards. * Support ... Consultant I (Entry-Level / Junior) * Experience: 0-3 years CSV or validation experience in GMP ...

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How much do gmp consultant jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for gmp consultant in the United States is $66.73, according to ZipRecruiter salary data. Most workers in this role earn between $55.53 and $80.77 per hour, depending on experience, location, and employer.

What is a GMP consultant?

A GMP (Good Manufacturing Practice) Consultant is a professional who helps businesses comply with regulatory standards for the production of pharmaceuticals, medical devices, food, and cosmetics. They assist in quality assurance, regulatory compliance, audits, and process improvements to ensure safety, consistency, and legal adherence. Their role often includes training staff, identifying compliance gaps, and preparing companies for inspections by regulatory bodies like the FDA or EMA.

What does a GMP consultant do?

A GMP Consultant’s daily responsibilities often include conducting facility audits, reviewing and developing SOPs, analyzing compliance gaps, and providing recommendations for process improvements. They may also deliver training sessions to staff, ensure documentation aligns with regulatory standards, and support client teams during inspections or regulatory submissions. GMP Consultants frequently collaborate with quality assurance, production, and regulatory affairs personnel, making strong interpersonal skills and clear communication crucial. This diverse mix of tasks provides opportunities to solve challenges and help organizations maintain high-quality standards.

What are the key skills and qualifications needed to thrive as a GMP consultant?

To thrive as a GMP Consultant, you need in-depth knowledge of Good Manufacturing Practices, quality assurance, and regulatory compliance, typically backed by a degree in life sciences or related fields. Familiarity with regulatory frameworks (such as FDA, EMA), audit processes, and systems like CAPA management or electronic QMS is essential, and certifications like GMP Professional or Six Sigma are advantageous. Strong analytical thinking, project management, and excellent communication skills are key soft skills for excelling in this role. These abilities ensure consultants can effectively guide organizations through complex regulatory landscapes, drive continuous improvement, and maintain compliance within highly regulated industries.

Are GMP Consultant jobs in demand?

GMP (Good Manufacturing Practice) consultants are in steady demand due to the ongoing need for compliance in pharmaceutical, biotech, and food manufacturing industries. Their expertise in regulatory standards, quality systems, and validation processes makes them valuable, especially as regulations evolve and companies seek to ensure product safety and quality.

How to become a GMP consultant?

To become a GMP (Good Manufacturing Practice) consultant, individuals typically need a background in life sciences, pharmacy, or engineering, along with experience in pharmaceutical or biotech manufacturing. Obtaining certifications such as the Certified Quality Auditor or GMP-specific training can enhance credibility, and strong knowledge of regulatory requirements from agencies like the FDA is essential. Gaining practical experience and staying current with industry standards are key steps in establishing a career as a GMP consultant.
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Gmp Consultant jobs near you
Infographic showing various Gmp Consultant job openings in the United States as of August 2026, with employment types broken down into 90% Full Time, 6% Part Time, and 4% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $138,790 per year, or $66.7 per hour.

Consultant, Global Regulatory Affairs

Cullgen Inc.

San Diego, CA • On-site

$150 - $210/hr

Other

Re-posted 17 days ago

Job description

Position Summary:

Our ideal Consultant will bring a high level of strategic thinking paired with a get-things-done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment. The successful candidate will work with the team in compiling the original submissions of IND and CTA as well as EOP2, response to Health Authority queries as well as oversight of all aspects of regulatory activities. The candidate will also oversee the quality function including working with the company’s GMP consulting firm, GCP consultants and build the quality function over time. The candidate will assure appropriate SOPs are updated and in place for the stage of development of the company.

You will support our clinical programs (Preclinical, Phase 1, 2, 3) and planned future commercial launch. This position will be an integral part of designing and advancing the company’s effort to discover, develop and commercialize our pipeline of therapeutics.

Responsibilities:
  1. Develop and implement regulatory strategy across a growing pipeline of early- and mid-stage development programs, with a focus on the successful registration of these products.
    • Enable creative solutions to regulatory challenges to efficiently advance novel therapeutics to key development milestones including positioning for successful pivotal trials and registration.
    • Ensure effective risk management and communication of issues/risks across the portfolio and participate in driving prioritization of resource and spend.
    • Plan, oversee and participate in all regulatory activities, including regulatory submissions (INDs, NDAs, MAAs, CTAs etc.), preparation and leading of agency meetings.
  2. Serve as the company contact with the FDA and other regulatory authorities.
  3. Ensure all external data complies with required specifications, standards, protocols, SOPs and overall clinical objectives. Help ensure the continued development, review and updating of SOPs and process documentation in accordance with corporate, industry and regulatory agency standards.
  4. Direct and assist internal staff and consultants, to ensure the compliance of R&D activities with U.S. and international requirements.
Requirements:
  • 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
  • Ph.D., PharmD or other relevant post-graduate level training strongly preferred.
  • Excellent working knowledge of regulatory regulations, guidelines, and all phases of clinical drug development.
  • Experience with Pre-IND, Pre-phase 2 and Type D meetings and responses needed.
  • Ability to lead and advise under pressure, respond to complex operational challenges with innovative solutions supported by appropriate tactics.
  • Ability to occasionally work onsite from our San Diego offices.
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About Cullgen

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

11 - 50 Employees

Headquarters location

San Diego, CA, US

Year founded

2018

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