Job Openings >> Quality Assurance Manager, QMS and Document Control
Quality Assurance Manager, QMS and Document Control
Summary
Title:Quality Assurance Manager, QMS and Document Control
ID:1027
Location:Philadelphia, PA
Department:N/A
Description

About SwanBio Therapeutics

SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success.SwanBio’s lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Syncona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases. SwanBio offers all team members both competitive compensation and benefits.

The Opportunity

We are seeking a collaborative and technically motivated QA Manager with multi-disciplinary expertise to join our Quality Assurance Team. The scope includes all aspects of the manufacturing of AAV-based gene therapies focusing on the implementation, oversight and maintenance of the QMS (deviations, change control, CAPA), document management, and training programs.

Key Responsibilities

  • Develop, implement and run systems to support manufacturing and testing both internal and external to the organization
  • Assist in the planning and conducting of audits in support of in-house analytical testing to ensure health authority regulations and guidelines
  • Oversee and manage of GMP/GLP inspections
  • Assist in the development of corrective and preventive actions when appropriate and ensure effective reporting mechanisms are developed and followed
  • Establish performance criteria, monitor results, coach and develop knowledge and competencies of team members involved in GMP/GLP
  • Develop and oversee the QMS
  • Conduct GMP audits or followed participate in other quality assurance work
  • Maintain knowledge of current quality and GMP/GLP practices, literature and applicable professional regulations and theories in field of expertise
  • Manage the development, execution, review, and/or approval process of all controlled documents, including SOPs, deviations, investigations, change requests, CAPAs.
  • Act as expert regarding QMS subjects
  • Ensure the internal quality management system within analytical development is developed and maintained
  • Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms, and tools
  • Identify and communicate quality or compliance risks and participate in establishment of appropriate plans to address the risks
  • Schedule, plan and perform CMO, CRO and/or laboratory audits
  • Ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause.

Basic Requirements:

  • BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience
  • Minimum 3-5 years of biopharmaceutical experience, including 3 years in a quality/regulatory function required
  • Must have experience working with large molecules, gene therapy experience a plus
  • Must have knowledge for the development of QMS and implementing electronic QMS, document control and training programs
  • Practical knowledge of how to identify key performance quality metrics
  • Experience with developing relationships
  • Ability to work under challenging deadlines and be accountable for completing work within specific project timelines
  • Strong detail orientation, organization and focus on quality work product
  • Proficient in MS Office Suite
  • Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly
  • Excellent verbal and written communication skills

About the Benefits:

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including medical, dental, vision care, 401(k), paid vacation and holiday time.

SwanBio Therapeutics is an equal opportunity employer

 

This opening is closed and is no longer accepting applications
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