Vice President and Head of Quality and Compliance

Job Locations US-NJ-Florham Park
ID
2021-1338
Category
Technical Operations/ Manufacturing
Type
Regular Full-Time

Overview

Celularity is a next-generation Biotechnology company creating off-the-shelf cellular medicines for Cancer, Infectious Diseases, and Degenerative Diseases.  Our employees are experienced cellular medicine leaders and innovators and are revolutionizing the way the industry approaches disease.

 

Reporting to the Executive Vice President and Chief Technology Officer, the Vice President and Head of Quality and Compliance will be responsible for all aspects of the company’s quality organization and capabilities including Quality Systems and Compliance, Quality Engineering, Quality Control, QC-Micro, Quality Operations and GCP.  We are looking for an experienced leader who will help us build an organization fit-for-growth to successfully deliver life-changing therapies to the patients we serve.

Responsibilities

  • Responsible for the strategic development and deployment of Celularity’s quality operating model including quality sub-functions and their capabilities.
  • Represents all Quality functions on the Technical Operations Leadership Team
  • Ensures GMP compliance while building teams and developing people to create a culture of quality excellence.
  • Directs and oversees Quality Systems and Compliance including technical training, document control, compliance, inspection readiness, quality systems, quality management reviews, supplier quality and internal/external audits.
  • Collaborating closely with F&E, IT and manufacturing, build and maintain a robust Quality Engineering organization responsible for CQV, risk assessments, data integrity and computer system validation.
  • Accountable for all aspect of Quality Control including analytical, specifications, sample management, stability, LIMS, raw material testing and support technical regulatory submissions.
  • Build and deploy a QC-Micro team that delivers testing, environmental monitoring, methods and supports facility qualification.
  • Working closely with manufacturing and process development, leads a Quality Operations group that supports deviation resolution, CAPA, MRB and EBS.
  • Oversees a team who are responsible for clinical sites / CRO vendor audits and pharmacovigilance.
  • Drives continuous improvement through effective organizational management, budgeting, reporting, project management and operational excellence within the function.

Qualifications

  • Degree in the biological sciences; PhD or MS preferred.
  • 15 years of technical experience in GMP pharmaceutical or biologics manufacturing environment.  Cell Therapy experience is preferred.
  • Experience in both QC and QA is preferred with 10 years of experience in a supervisory Quality management role.
  • Demonstrated ability to successfully interact with health authorities at regulatory meetings and inspections.
  • Strong understanding of cGMP, GLP, GCP and GvP compliance requirements associated with US, EU, ICH and other pertinent regulatory agencies.
  • Robust understanding of fundamental quality concepts including aseptic manufacturing, process validation and control and technology transfer.
  • Proven ability to make objective, inclusive, robust an unbiased decision with imperfect information.
  • High degree of emotional intelligence, strong listening skills and exceptional written and verbal communication abilities.

 

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