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Cgmp Consulting Jobs (NOW HIRING)

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR · On-site

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

MMR Consulting

PR

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and ... Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ...

Quality Consulting Group

JT908 - MACHINIST I

Aibonito, PR · On-site

$20.75 - $28.25/hr

Conocimiento de entrenamientos y requisitos relacionados con cGMP. * Disponibilidad para Turnos: 6am-6pm Sabado y Domingo con 2 días en turno 10:00pm a 6:00am en la semana. Quality Consulting Group ...

Mirus Consulting Group

Specialits QA - 35669

Juncos, PR · On-site

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer ... Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes ...

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How much do cgmp consulting jobs pay per year?

As of Sep 1, 2026, the average yearly pay for cgmp consulting in the United States is $80,827.00, according to ZipRecruiter salary data. Most workers in this role earn between $50,000.00 and $105,500.00 per year, depending on experience, location, and employer.

What is cGMP consulting?

cGMP consulting refers to professional advisory services that help pharmaceutical, biotechnology, and related industries comply with current Good Manufacturing Practices (cGMP) regulations. These consultants provide expertise in regulatory requirements, quality assurance, process improvement, and inspections to ensure that manufacturing processes meet FDA or international standards. cGMP consultants can assist with audits, training, documentation, and remediation to help companies maintain compliance and avoid regulatory issues.

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

To excel as a CGMP Consultant, you need a solid background in pharmaceutical or biotech manufacturing, in-depth knowledge of current Good Manufacturing Practices (CGMP), and often a relevant science or engineering degree. Familiarity with regulatory databases, quality management systems (QMS), and certifications like Six Sigma or ASQ-CQA is highly beneficial. Strong analytical thinking, communication, and problem-solving skills help you effectively guide clients through regulatory compliance and process improvements. These skills are vital to ensure product quality, regulatory adherence, and the successful implementation of best practices within client organizations.

What are some common challenges faced by professionals in cGMP consulting, and how can they be addressed?

CGMP consultants often face challenges such as staying current with evolving regulations, managing client expectations, and adapting best practices to diverse manufacturing environments. To address these, consultants must engage in ongoing professional development, maintain strong relationships with regulatory bodies, and develop tailored compliance strategies for each client. Effective communication and proactive problem-solving also help ensure successful project outcomes and build client trust.

What does cGMP Consulting do?

cGMP consulting involves providing expertise to ensure pharmaceutical, biotech, and medical device companies comply with current Good Manufacturing Practices (cGMP) regulations. Consultants assist with quality systems, validation, audits, and regulatory submissions to maintain product safety and compliance standards.
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Cgmp Consulting jobs near you
Infographic showing various Cgmp Consulting job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 80% Full Time, 15% Part Time, and 4% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution, with an average salary of $80,827 per year, or $38.9 per hour.

GMP Manufacturing & Quality Systems Gap Assessment Consultant - 2-Day Onsite in Pennsylvania

The FDA Group

Boston, MA

Full-time

Posted 10 days ago

Job description

Manufacturing & Quality Systems Gap Assessment Consultant

Location: Onsite – Pennsylvania
Work Arrangement: 2-day onsite assessment with additional offsite assessment and reporting activities
Duration: Approximately 40–45 total project hours; completion prior to the end of September
Schedule: 2 days onsite, with remaining project hours dedicated to assessment preparation, analysis, and reporting

Position Overview

A regulated manufacturing organization is seeking an experienced consultant to conduct a comprehensive gap assessment of its manufacturing and quality systems.

The consultant will evaluate current operations against applicable FDA regulatory requirements, current Good Manufacturing Practice (cGMP) regulations, and relevant industry standards using a systematic, risk-based approach.

The assessment will place particular emphasis on defect identification and extrinsic particle controls, as well as regulatory and GMP requirements associated with hormone manufacturing. The consultant will quantify identified gaps and provide practical recommendations for corrective and preventive actions (CAPAs).

Key Responsibilities

  • Conduct a systematic, risk-based gap assessment of manufacturing and quality systems against applicable FDA requirements, cGMP regulations, and industry standards.

  • Perform a 2-day onsite assessment of relevant manufacturing operations and quality systems.

  • Evaluate the organization's approach to defect identification and identify gaps affecting regulatory compliance.

  • Assess regulatory expectations related to extrinsic particles and, where appropriate, evaluate acceptable thresholds and associated controls.

  • Assess regulatory and GMP requirements for the setup, operation, and handling of hormone manufacturing activities.

  • Identify and document observations, deficiencies, and compliance risks identified during the assessment.

  • Provide quantifiable assessment results that enable the organization to understand and prioritize identified gaps.

  • Recommend appropriate CAPAs to address identified observations and deficiencies.

  • Provide practical, risk-based recommendations to strengthen manufacturing and quality systems and support ongoing compliance.

Required Qualifications

  • Strong knowledge of applicable FDA regulatory requirements and cGMP regulations for regulated manufacturing operations.

  • Demonstrated experience conducting manufacturing and quality systems gap assessments.

  • Ability to apply systematic, risk-based assessment methodologies.

  • Experience identifying compliance gaps and developing appropriate CAPA recommendations.

Preferred Qualifications

  • Former FDA experience.

  • Experience evaluating defect identification programs and controls related to extrinsic particles.

  • Experience with regulatory and GMP considerations associated with hormone manufacturing.

Work Arrangement

The engagement includes a 2-day onsite assessment in  Pennsylvania, followed by the analysis, documentation, and reporting activities necessary to complete the assessment. The total engagement is expected to require approximately 40–45 hours and be completed prior to the end of September.

Ideal Candidate

The ideal consultant is an experienced FDA compliance and cGMP professional, preferably with former FDA experience, who can independently assess manufacturing and quality systems, identify and quantify compliance gaps, and translate findings into practical, risk-based CAPA recommendations.