Quality Manager


Bethlehem, PA

Industry: Biotech/Pharma


5 - 7 years

Posted 376 days ago

The candidate must be highly organized with ability to support and maintain our key initiatives and core values. Ensures cross-training of all manufacturing Quality staff so that all internal and external (service/installations) needs are met. Maintains and ensures standard operating procedures (SOPs).

 Support and maintain our quality practices and guidelines, including best industry practices such as Good Documentation Practices (GDP). Quality System Auditing by participating in internal process and mock customer audits, perform vendor qualificationaudits, and coordinate third party audits of specified site as directed (ASME, National Board, etc.). Coordinate team involvement in Pre-FAT, FAT, SAT, and IQ/OQ activities. Serve as a site CAPA mentor for assigned champions from other functions. Coordinate Quality System Change Management and calibration activities as specified at facility.

Bachelor’s Degree in an Engineering discipline or related Science field (ex. Chemistry, Metallurgy)

  • A Minimum 5years post graduate work in a Quality or Validation fields.
  • 5years of proven ability to lead, supervise and coach a team of 10 quality staff.
  • Report to the Global Director of Quality the status and KPI metrics of the quality program for specific site such as First pass Yields (from monitored Mfg. Processes), Turnover Package (TOP)Audits, ECN Review, MRB cycle times, Receiving Inspections, Trend Analysis of FAT/SAT punchlist items.
  • Experience with Corrective Action and Preventive Action (CAPA) is required.
  • Coordinate assigned CAPA activities (Root cause analysis, short and long term corrective and preventive action).
  • Certifications in cGMP, ISO9, ASME, BPV or equivalent is required.
  • Must be able to travel domestically and internationally.
  • Review and evaluate site quality staff performance experience is preferred
  • Experience with Site Liaison with authorized inspection (AI) Agency personnel (Vessel Manufacturing sites only) is preferred.
  • ASQ CQE, ASQ CQM and Six Sigma would be a plus