GMP Operational Quality Senior Specialist (Pharmaceuticals)

TL;DR

GMP Operational Quality Senior Specialist (Pharmaceuticals): Supporting quality assurance and regulatory compliance for commercial product stability programs with an accent on analytical data review, deviation investigations, and CAPA management. Focus on collaborating with cross-functional teams and external partners to ensure adherence to global GMP requirements and continuous improvement initiatives.

Location: Must be based in or able to work on-site in Boston, MA (Hybrid or On-Site options available).

Salary: $94,200 - $141,200

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Provide QA review of GMP data to support commercial product stability programs.
• Collaborate with internal and external business partners to resolve quality issues and ensure compliance.
• Represent QA Analytical on cross-functional teams as a technical quality resource.
• Oversee Root Cause Analysis (RCA) and product impact assessments for deviations and OOS/OOT investigations.
• Support stability-impacting change control activities, including assessment and implementation.
• Conduct GMP document reviews, including procedures, specifications, methods, and protocols.

Requirements

• Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• 3-4 years of experience in an operational QA role within an analytical or manufacturing setting.
• Advanced knowledge of cGMP regulations and their practical application in a pharmaceutical environment.
• Experience with Root Cause Analysis tools, technical writing, and electronic document management systems (e.g., LIMS, Veeva).
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Must be authorized to work in the United States.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Commuting subsidy and charitable donation matching.
• Flexible work arrangements through the Flex @ Vertex program.