Quality Control Manager

Lewes, Delaware

Position Summary

This role will lead the Quality Control function at SPI’s Lewes manufacturing site and reports directly to the Site Quality Head

The primary objective of this position is to manage the Quality Control laboratory ensuring the integrity of all testing, methods and procedures to support manufacturing and release of products while ensuring that compliance with regulatory requirements and consistent with customer specifications.

Essential Duties and Responsibilities

  • Supervises all QC laboratory functions and serves as a technical lead in managing laboratory activities
  • Reviews and approves laboratory deviations and OOS Investigations
  • Reviews and trends laboratory data to support APRs and process improvements
  • Works with site management to set priorities within the laboratory based on production schedule, stability commitments, investigations and site projects
  • Oversees and assures lab compliance and safety
  • Ensure that programs for instrument calibration, maintenance and qualification are robust and to current standards
  • Develops QC staff and assures that all personnel are properly trained
  • Oversees Out of Specifications program ensuring compliance with current standards
  • Independently develops and recommends improvements to processes or procedures to drive efficiency through improved testing accuracy, turnaround time and compliance.
  • Support customer and regulatory inspections

Leadership Traits

  • Honesty, integrity, and the ability to work collaboratively, respectfully and safely
  • A strong contributor with the ability to effectively manage up, down, and across the organization
  • Drives accountability within the organization
  • Leads by example and actively engages appropriate personnel to make informed decisive decisions
  • Demonstrate ability to organize self and others, with a positive, proactive approach to changing priorities
  • Effective clear and concise communication

Supervisory Responsibilities

This position will have two (2) direct reports.

Education and/or experience

  • Minimum B.S. in Chemistry or related science field
  • 5-10 years’ experience with increasing supervisory responsibility in a Pharmaceutical QC laboratory
  • Strong understanding of compendial methods and wet chemistry techniques
  • Experience in QC raw material laboratory and API setting preferred
  • Ability to delegate and inform management of priority issues
  • Working knowledge of LIMS, QMS, QRM, Label controls and Enterprise System
  • 2-4 years’ experience in method development and validation
  • Experience building teams and developing strong collaborative relationship among Skills
  • A natural problem solver with a sound working knowledge and application of formal root cause analysis tools
  • Demonstrate ability to organize self and others, with a positive, proactive approach to changing priorities

Travel Requirements

The position will be located at the SPI Pharma Lewes Manufacturing Site.