Director, Quality Inspection Readiness

Our Immunotherapy client located in Lexington, MA is looking to add an AD/Director, GxP Quality Inspection Readiness to their team!  Role will be responsible for providing leadership and oversight for Inspection Readiness (IR) activities ensuring the company remains inspection ready and can act nimbly to facilitate any regulatory inspection/audit in a timely manner as required by regulatory requirements.

This individual will be responsible for leading our global IR activities, including but not limited to preparation of company’s sites and IR teams, coordinating IR activities during an inspection or site audit, coordinating responses to inspection or audit finding and coordinating our Internal Audit Program. They will also be responsible for managing and steering our GxP Quality System maturity through the management of our Quality System Maturity Model (QSMM). As a leader in the Quality organization, the candidate is expected to share their diverse background to support and mentor other quality activities and/or personnel as an active participant on the Quality Team.

Responsibilities (including, but not limited to):

  • Inspection Readiness (IR):
    • Prepare for U.S. Food and Drug Administration or other Health Authority inspections of company or clinical trial sites
    • Lead GxP inspection readiness activities, to include but not limited, to staff and vendor preparations, logistics, playbook development, mock audits/inspections, training of our staff, maintaining IR presentations and tools and managing our backroom activities during inspections/audits as the backroom manager
    • Coordination of our Internal Audit program, including proactive management of any Corrective and Preventive Actions (CAPA) to address observations
  • Quality System Maturity Model (QSMM):
    • Drive the maturing of GxP Quality Systems through the QSMM and ensuring a risk-based and phase appropriate approach
    • Provide ownership for the QSMM database and drive systematic evaluations
    • Assist Head of Quality Systems ensure appropriate quality systems are in place and remain effective
    • Ensure Quality System standards and procedures remain in alignment with industry standards and regulations
  • General:
    • Develop and maintain the internal standards and procedures
    • Ensures adherence to GxP requirements and SOPs including training plans and training
    • Proven experience in leading all aspects of IR and active participation in hosting/supporting inspections/audits in a GxP environment

Requirements:

  • Requires a Bachelors or Advanced degree in a scientific discipline with 7+ years’ experience in the pharmaceutical/biotech industry and 3 years Management experience
  • Understanding of requirements of GxP and quality systems for commercial and clinical products
  • Proven experience applying risk management principles
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work and drive change across functions
  • Experience interacting with regulatory health authorities at pre- and post-approval inspection
  • Ability to evaluate Quality Systems and drive value added enhancements
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • Excellent team building, leadership and management skills
  • Consistent delivery of high-quality work at all times
  • Outstanding skills in managing Quality and Regulatory activities to meet corporate objectives