Overview
On Site
Depends on Experience
Contract - Independent
Contract - W2
Contract - 12 Month(s)
Skills
Auditing
CMOS
Change Control
Communication
Corrective And Preventive Action
Management
Manufacturing
Manufacturing Operations
Pharmaceutics
Job Details
Position: Compliance Specialist Consultant
Location: New York 100% Onsite
Project Overview:
A leading pharmaceutical company in New York is seeking a Compliance Specialist Consultant to support the External Manufacturing Compliance team. This is a critical on-site role required due to a rapidly increasing workload. The consultant will oversee Quality System activities related to Change Control, Deviations, CAPAs, and interactions with CMOs (Contract Manufacturing Organizations).
You will serve as the owner of key compliance records, ensuring that all external manufacturing processes (clinical and commercial) meet quality and regulatory standards.
Project Scope & Responsibilities:
Own and manage Change Control, CAPAs, and SCARs for clinical and commercial external manufacturing
Ensure compliance of outsourced processes (filling, packaging, drug substance) from CMOs
Lead and facilitate status update meetings, manage priorities, and track progress
Collaborate with External Manufacturing Operations relationship leads
Author, review, and revise SOPs for continuous process improvement
Support and participate in audits and quality system reviews
Project Overview:
A leading pharmaceutical company in New York is seeking a Compliance Specialist Consultant to support the External Manufacturing Compliance team. This is a critical on-site role required due to a rapidly increasing workload. The consultant will oversee Quality System activities related to Change Control, Deviations, CAPAs, and interactions with CMOs (Contract Manufacturing Organizations).
You will serve as the owner of key compliance records, ensuring that all external manufacturing processes (clinical and commercial) meet quality and regulatory standards.
Project Scope & Responsibilities:
Own and manage Change Control, CAPAs, and SCARs for clinical and commercial external manufacturing
Ensure compliance of outsourced processes (filling, packaging, drug substance) from CMOs
Lead and facilitate status update meetings, manage priorities, and track progress
Collaborate with External Manufacturing Operations relationship leads
Author, review, and revise SOPs for continuous process improvement
Support and participate in audits and quality system reviews
Requirements:
BS degree (Science, Engineering, or related field)
Minimum 5 years of experience in the pharmaceutical industry
Experience working with external partners such as CMOs or corporate collaborators
In-depth experience as a Quality System record owner (Change Control, CAPA, Deviations)
Strong communication and technical writing skills
Experience authoring, reviewing, or auditing SOPs is preferred
Experience in External Manufacturing or QA role is highly desirable
BS degree (Science, Engineering, or related field)
Minimum 5 years of experience in the pharmaceutical industry
Experience working with external partners such as CMOs or corporate collaborators
In-depth experience as a Quality System record owner (Change Control, CAPA, Deviations)
Strong communication and technical writing skills
Experience authoring, reviewing, or auditing SOPs is preferred
Experience in External Manufacturing or QA role is highly desirable
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