About the role
Description Hybrid onsite 2 weeks per month in Lebanon, IN Our client seeks a Quality Assurance Specialist to manage the end-to-end lifecycle of quality agreements across suppliers, service providers, contract manufacturers, and laboratories in a regulated pharmaceutical setting. The specialist will draft, negotiate, execute, and track agreements while coordinating with QA, Procurement, Legal, and Regulatory Affairs to maintain timelines and compliance. The role will support supplier qualification, manufacturing readiness, and continuous improvement of templates and workflows. The position reports to the Associate Director of QA.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $75.00 to $90.00/hr. w2
Responsibilities
- Draft, review, revise, negotiate, and execute quality agreements for external partners including suppliers, service providers, contract manufacturers, and contract laboratories.
- Manage the full lifecycle of quality agreements from initiation through closure while ensuring adherence to program timelines and supplier qualification milestones.
- Collaborate cross-functionally with QA, Procurement, Legal, Regulatory Affairs, and external partners to align on agreement language, resolve redlines, and obtain required approvals.
- Maintain accurate documentation, version control, and status tracking of quality agreements within applicable quality management systems and workflow tools.
- Identify, communicate, and escalate risks or delays that may impact supplier qualification, manufacturing readiness, or regulatory compliance.
- Support continuous improvement initiatives related to quality agreement templates, workflows, and process standardization.
- Assist with additional QA and compliance activities as needed to support broader organizational priorities.
Experience Requirements
- Minimum 3 to 5 years in a regulated pharmaceutical, biotechnology, or life sciences environment supporting Quality Assurance, Supplier Quality, Compliance, or Quality Systems functions.
- Demonstrated experience drafting, reviewing, negotiating, and managing quality agreements or similar GxP-controlled documentation.
- Working knowledge of GMP regulations including 21 CFR Parts 210 and 211, ICH Q7, ICH Q10, EU GMP Chapter 7 and Annex 16, and FDA guidance related to contract manufacturing and quality agreements.
- Experience with quality management and document control systems such as QDocs and Veeva Vault.
- Familiarity with USP and ICH Q6A/Q6B standards (preferred).
- Familiarity with procurement and contract management systems such as SAP or Ariba (preferred).
- Proficiency with Microsoft Office Suite, Adobe Acrobat, Microsoft Teams, and workflow tracking tools such as Smartsheet.
- Strong cross-functional collaboration experience with QA, Procurement, Legal, and Regulatory Affairs.
- Proven ability to manage multiple concurrent agreements, deliverables, and competing priorities in a deadline-driven environment.
Education Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biochemistry, Engineering, or a relevant scientific or technical discipline.
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