Quality Assurance Specialist

United Pharma; Indiana (PA); On-site; USD 85,000 - 120,000; Full time

Job summary

United Pharma is seeking a Quality Assurance Specialist to lead end-to-end quality agreements with suppliers, contract manufacturers, and laboratories in a regulated pharma setting.

The role requires experience drafting and negotiating GxP documentation, with strong GMP knowledge and FDA guidance familiarity. Collaborate with QA, Procurement, Legal, and Regulatory teams to ensure compliance and proper records throughout the lifecycle.

Qualifications

• 3–5+ years in a regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience supporting Quality Assurance, Supplier Quality, Quality Systems, Compliance, or related functions.
• Demonstrated experience drafting, reviewing, negotiating, and managing Quality Agreements or similar GxP-controlled documentation.
• Working knowledge of GMP regulations and pharmaceutical quality requirements.
• Knowledge of FDA guidance and regulatory expectations related to contract manufacturing and quality agreements.

Responsibilities

• Draft, review, revise, negotiate, and execute Quality Agreements with suppliers, service providers, contract manufacturers, and contract laboratories.
• Manage the complete lifecycle of quality agreements, from initiation and review through approval, execution, maintenance, and closure.
• Coordinate quality agreement activities to ensure alignment with supplier qualification milestones, project timelines, and manufacturing readiness requirements.
• Collaborate with QA, Procurement, Legal, Regulatory Affairs, and external partners to resolve comments, redlines, and contractual quality requirements.
• Ensure agreements are properly routed for review and approval and maintain accurate records throughout the approval process.

Skills

Quality Assurance

Regulatory knowledge

Contract management

GxP experience

Tools

Veeva Vault

QDocs

Job description

Our client is seeking a Quality Assurance Specialist – Quality Agreements to manage the end-to-end lifecycle of quality agreements with suppliers, service providers, contract manufacturers, and contract laboratories in a regulated pharmaceutical environment. The specialist will be responsible for drafting, reviewing, negotiating, executing, and tracking quality agreements while partnering closely with Quality Assurance, Procurement, Legal, Regulatory Affairs, and external partners.

Key Responsibilities:

• Draft, review, revise, negotiate, and execute Quality Agreements with suppliers, service providers, contract manufacturers, and contract laboratories.
• Manage the complete lifecycle of quality agreements, from initiation and review through approval, execution, maintenance, and closure.
• Coordinate quality agreement activities to ensure alignment with supplier qualification milestones, project timelines, and manufacturing readiness requirements.
• Collaborate with QA, Procurement, Legal, Regulatory Affairs, and external partners to resolve comments, redlines, and contractual quality requirements.
• Ensure agreements are properly routed for review and approval and maintain accurate records throughout the approval process.

Required Qualifications:

• 3–5+ years of experience in a regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience supporting Quality Assurance, Supplier Quality, Quality Systems, Compliance, or related functions.
• Demonstrated experience drafting, reviewing, negotiating, and managing Quality Agreements or similar GxP-controlled documentation.
• Working knowledge of GMP regulations and pharmaceutical quality requirements.
• Knowledge of 21 CFR Parts 210 and 211, ICH Q7, ICH Q10, EU GMP Chapter 7, and EU GMP Annex 16.
• Familiarity with FDA guidance and regulatory expectations related to contract manufacturing and quality agreements.
• Experience working with QMS and document management systems, such as Veeva Vault or QDocs.