Capital Associated Industries, Inc.
  • Raleigh, NC, USA
  • Full Time

Overview: 

 

The Quality Systems Manager develops, sets expectations, implements and manages an integrated vision for the Cellectis Quality System. The QA Manager exercises judgment within the Cellectis Quality System in seeking compliant and consensus solutions to challenges that may arise during daily activities. The QA Quality Systems Manager is responsible for identifying and implementing ongoing quality improvement processes working with interdepartmental teams as needed. The QA Quality Systems Manager develops, manages and presents quality assurance metrics to Quality Council as a mechanism to monitor and improve performance.  

 

Responsibilities:

 

  • Hires, develops, trains and evaluates Quality Systems personnel
  • Owns the corporate electronic applications for managing elements of the Cellectis Quality System (documentation/records management, change management, deviation/CAPA management, training) including:
    • Writing of User Requirement Specifications and Functional Specifications for an electronic Quality Management System (eQMS)
    • Choice of application vendor
    • Working directly with the e-system vendor and internal IT to facilitate configuration
    • Planning for phased implementation of the chosen electronic system including but not limited to:
      • System validation
      • Document migration
      • Training
      • Routine use
    • Works with colleagues to develop the Cellectis Quality Manual; Maintains the Quality Manual
    • Ensures and promotes compliance with applicable US and European CGMP regulations, corporate policies and company Standard Operating Procedures.
    • Provides input based on knowledge and experience of Quality Systems, procedures and CGMP issues.
    • Provides Quality Systems related support to all GMP departments
    • Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies
    • Maintains systems to track and trend key Quality System Indicators and ensure KPIs are addressed. Assures that any adverse trends or patterns are noted and are promptly addressed
    • Mentors/trains/develops Quality Systems Associates
    • Other duties as assigned by the Head of Quality or the Site Head

 

 Required Experience and Skills

 

  • BS or MS degree, preferably in a Life Science, with at least five (5) years of relevant QS experience in a biopharmaceutical company.
  • Working knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
  • Experience writing Quality Manuals, Policies, Standard Operating Procedures and Work Instructions
  • Knowledge and understanding of regulations regarding cell/gene manufacturing including but not limited to cGMP as defined by the US Food and Drug Administration and European Medicines Agency
  • Ability to adapt Quality System elements for Pharma to cell/gene manufacturing
  • Understanding of aseptic manufacturing
  • Strong written and verbal communication skills.
  • Accountable for making independent decisions regarding daily QA Quality Systems with minimal supervision
  • Ability to set and manage priorities and schedule activities accordingly
  • Strong analytical and problem solving skills
  • Demonstrated interpersonal skills to work effectively with subordinates, peers, managers and cross-functional teams
  • Excellent organizational skills with attention to detail and deadlines
  • Strong team orientation including the ability to coach and mentor

 

 

Capital Associated Industries, Inc.
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