GMP Operational Quality Senior Manager (Pharmaceuticals)

TL;DR

GMP Operational Quality Senior Manager (Pharmaceuticals): Leading quality assurance and compliance activities for complex pharmaceutical projects with an accent on GMP standards, deviation investigations, and CAPA management. Focus on cross-functional collaboration, continuous process improvement, and providing technical quality oversight to ensure regulatory compliance.

Location: Must be based in or able to commute to Boston, MA (Hybrid or On-Site).

Salary: $136,400 - $204,600

Company

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

What you will do

• Collaborate with internal and external partners to resolve complex quality issues and ensure compliant solutions.
• Assess and approve change controls while ensuring adherence to procedural requirements.
• Conduct quality investigations, deviations, and root cause analysis to determine product impact.
• Manage and approve CAPA actions to ensure timely resolution and compliance.
• Provide technical advice for partner and regulatory agency audits.
• Review GMP documentation including protocols, specifications, and method reports.

Requirements

• Bachelor's degree in a scientific or allied health field.
• Typically requires 6 years of relevant experience in a pharmaceutical setting.
• In-depth knowledge of conceptual and practical application of cGMPs.
• Strong experience leading event investigations, Root Cause Analysis (RCA), and CAPA.
• Proficiency with electronic document management systems such as Trackwise or Veeva.
• Must be authorized to work in the United States.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company matching.
• Generous paid time off including company-wide summer and winter shutdowns.
• Educational assistance programs and student loan repayment support.
• Flexible work arrangements with hybrid options available.