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.