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Quality Systems/Document Control Lead

Job Attributes

Job Id:

31785

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19104

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION

Piper Companies is looking for a Quality Systems/Document Control Lead in Philadelphia, PA (Center City) to lead QA Ops team on the implementation and administration of new electronic systems and solutions at a pharmaceutical company that develops gene therapies.


Reporting to the Quality Assurance Operations Lead, this position is accountable for the successful and timely completion of projects within Quality Assurance including:

  • Implementation of DMS and QMS systems
  • Manage integration between the LMS and DMS systems, as applicable
  • Responsible for KPI Management and Reporting
  • Identifies and implements Process Improvements
  • Leads Lean Excellence/Standardization of processes including issue identification and resolution for processes managed by the QA Ops group
  • Oversees Document Retention and File Room Management
  • Manages and Maintenances the Risk Register
  • Veeva


Responsibilities for the Quality Systems/Document Control Lead include:

  • Lead implementation and administration of new electric systems/solutions
    • Partner with doc control and Quality Systems teams
  • Strategic project execution & delivery, team management, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes
  • Provide input for overall systems strategy
  • Oversee 4-5 Junior Doc Control Specialists


Qualifications for the Quality Systems/Document Control Lead include:

  • 5+ years of regulated experience
    • Preferably in pharmaceutical or biotech industry
  • Prior supervisory experience
  • Must be able to work on multiple projects simultaneously  
  • Understands how to operate in a cross functional/matrix work environment
  • Hands on experience with GMP Compliant electronic systems for managing document control, deviations, CAPAs
  • Bachelors Required; Master's degree is a plus

Compensation for the Quality Systems/Document Control Lead include:

  • $90,000 - $115,000 & 15% performance based bonus
  • Full benefits 


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New Search

Job Id:

31785

Job Category:

Clinical & Life Sciences

Job Location:

Philadelphia, PA  19104

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions