• Serve as MasterControl system administrator, managing eDMS and eLMS processes.
  

• Provide guidance on the effective use of MasterControl to ensure compliance with company policies and industry standards.
  

• Oversee document control, including document lifecycle management and workflow approvals.
  

• Administer and manage the training program, including training assignments and records.
  

• Manage and review quality systems processes, including CAPAs, deviations, change controls, complaints, and investigations.
  

• Ensure compliance with ICH Guidelines, ISO9001, ISO13485, and phase-appropriate GMP regulations.
  

• Perform internal and external audits, including supplier qualifications and customer quality audits.
  

• Work directly with internal and external operational teams to ensure products meet quality standards and regulatory requirements.
  

• Develop and implement continuous improvement initiatives for internal quality systems and processes.
  

• Track and report on quality system metrics to support organizational goals.

 
Qualifications

• Bachelor’s degree (or equivalent) in Life Science or a related discipline; advanced degree preferred.
  

• 8+ years of experience in Quality Assurance, supporting manufacturing and quality control in the pharmaceutical or biotech industry.
  

• Direct experience as a MasterControl Administrator (eDMS and eLMS).
  

• Strong project management skills, with the ability to manage multiple priorities and meet deadlines.
  

• Experience in the oversight and approval of quality systems documentation.
  

• Knowledge of ICH Guidelines, ISO9001, ISO13485, and GMP regulations.
  

• Strong problem-solving, analytical, and organizational skills.
  

• Ability to work independently in a remote setting while effectively collaborating with cross-functional teams.
  

• Excellent communication and training skills to support system users and quality initiatives.

 
Preferred Qualifications

• Experience in fermentation/Downstream Processing (DSP) and Quality Control.
  

• Expertise in computerized system validation and implementation.
  

• Experience providing quality guidance to internal functional teams.

 
This is an exciting opportunity for a Quality Systems expert to make a significant impact by enhancing and optimizing our quality management processes. If you have the required expertise and a passion for quality excellence, we encourage you to apply!