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Senior Manager of Quality Operations

2 months ago

Morrisville, North Carolina, United States Jobot Full time
{"title": "Senior Manager of Quality Operations", "company": "Jobot", "location": "Remote", "job_type": "Full-time", "salary": "$130,000 - $160,000 per year", "benefits": "Bonus + Equity + 401(k) + Health Benefits", "job_description": "About the Job

We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatments for patients.

Responsibilities
  • Oversee CMO to ensure products manufactured are produced in accordance with regulatory requirements, product registrations, and quality agreements
  • Perform batch record reviews and lot dispositions
  • Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls and annual product quality reviews (APQRs)
  • Review and approve controlled documents, including clinical and commercial manufacturing and packaging master batch records, protocols and final reports
  • Support internal and external stakeholders with DSCSA and Distribution activities
  • Work with Quality Systems and CMC team to ensure quality and technical documentation is delivered to the internal archiving system
  • Facilitate new supplier intakes, supplier qualifications, and update and maintain Quality Agreements with suppliers
  • Provide guidance, advice, and support for GMP quality and compliance
  • Represent Quality as PIP at CMO's as necessary to support production operations
  • Travel 10% of time (domestic and international), including visits to CMOs and offices in NC, NJ, and NY
Requirements
  • University degree in life sciences or related fields
  • 5+ years' experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry
  • Thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with qualified person (QP) is a plus
  • Experience supporting clinical phase through commercial and lifecycle management
  • Experience in oversight of contract manufacturing
  • Proficiency in electronic QMS Software such as Veeva
  • Knowledge of cell-based or gene therapies is desired
  • Knowledge of medical device and combination product is desired
  • Knowledge of DSCSA requirements is desired
  • Excellent attention to detail, organizational and time management skills
  • Strong written and oral communication skills
", "apply_now": "Easy Apply now by clicking the \"Apply Now\" button."}