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Quality Operations Manager

2 months ago

Morrisville, North Carolina, United States Jobot Full time
Compensation Package: Bonus + Equity + 401(k) + Remote Work Options

About Us:
We are an innovative therapeutics firm with a market-approved medication, utilizing advancements in B-cell biology to create groundbreaking treatments for patients.

Why Work With Us?
  • Competitive Salary Structure
  • Annual Performance Bonuses
  • Equity Opportunities (RSUs)
  • 401k Retirement Plan
  • Flexible Remote Work
  • Comprehensive Health Benefits
  • Commercially Available Drug


Position Overview:
We are seeking a Quality Operations Manager/Senior Manager to oversee quality assurance for our biologics commercial and clinical development initiatives.

Key Responsibilities:
  • Supervise Contract Manufacturing Organizations (CMOs) to ensure compliance with regulatory standards, product registrations, and quality agreements.
  • Conduct batch record evaluations and lot dispositions.
  • Manage and assess product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
  • Review and authorize controlled documents, including clinical and commercial manufacturing and packaging master batch records, protocols, and final reports.
  • Assist internal and external stakeholders with DSCSA and distribution processes.
  • Collaborate with Quality Systems and CMC teams to ensure quality and technical documentation is accurately archived.
  • Facilitate new supplier onboarding, supplier qualifications, and maintain Quality Agreements with suppliers.
  • Provide expert guidance and support for GMP quality and compliance.
  • Represent Quality as a PIP at CMOs as needed to support production activities.
  • Travel up to 10% of the time for domestic and international visits to CMOs and relevant offices.


Qualifications:
  • Bachelor’s degree in life sciences or a related field.
  • Minimum of 5 years of experience in GMP Quality or Manufacturing within the biopharma/biologics/pharma sector.
  • In-depth understanding of GMP regulations; experience with FDA, EMA, or other regulatory bodies during inspections is advantageous.
  • Experience in supporting clinical phases through to commercial and lifecycle management.
  • Proven experience in overseeing contract manufacturing.
  • Proficiency in electronic Quality Management Systems (QMS) such as Veeva.
  • Familiarity with cell-based or gene therapies is preferred.
  • Knowledge of medical devices and combination products is a plus.
  • Understanding of DSCSA requirements is beneficial.
  • Exceptional attention to detail, organizational, and time management skills.
  • Strong written and verbal communication abilities.


We look forward to discussing this opportunity further.