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

 

Powered by ApplicantStack