Interim Industrial Executive – Regulated Healthcare Environment

2 weeks ago

Toronto, Ontario, Canada xNorth™ - Executive Interim Management Full time $120,000 - $180,000 per year

Interim Industrial Executive – Regulated Healthcare Environment (FDA Standards)

Contract Type: Interim Management

Location: Ontario (if required, all housing and logistics arrangements will be handled by xNorth)

Duration: Short-term assignment

Context

A manufacturing site operating in a highly regulated healthcare environment has recently completed major investments to modernize its production systems and align fully with FDA requirements. The site continues to be subject to close regulatory oversight and must demonstrate ongoing control and consistency in its quality and operational performance.

To reinforce this process, the corporate sponsor is seeking an experienced interim executive to ensure daily operational monitoring, maintain FDA compliance vigilance, and provide structured reporting on all progress and deviations with potential regulatory impact.

Core Mission

The mission consists in providing detailed follow-up of production and quality operations on behalf of the corporate sponsor, with a specific focus on compliance to FDA expectations.

The Interim Industrial Executive will be responsible for tracking, analyzing, and reporting daily on operational progress, CAPA execution, qualification status, and documentation accuracy, ensuring that the site remains inspection-ready and fully compliant at all times.

Key Responsibilities

  • Conduct daily oversight of production, quality, and validation activities with attention to FDA compliance and data integrity.
  • Monitor key deliverables such as equipment qualification, process performance, CAPA closure, and documentation control.
  • Report daily to the corporate sponsor on progress, deviations, and any event with regulatory or operational implications.
  • Support and challenge local teams to maintain FDA standards in both execution and mindset.
  • Verify consistency between operational practices, site quality systems, and FDA expectations.
  • Proactively identify and escalate compliance or performance risks.
  • Contribute to sustaining inspection readiness and regulatory discipline throughout the mission.

Required Profile

  • Proven leadership experience as Industrial Director, Production Director, Quality Director, or General Manager in FDA-regulated manufacturing (pharmaceutical, biotech, or healthcare).
  • In-depth understanding of FDA quality systems, sterile or controlled environments, and inspection protocols.
  • Demonstrated ability to lead multidisciplinary teams under time pressure and maintain compliance integrity.
  • Excellent communication skills
  • Prior exposure to U.S. or North American regulatory contexts is strongly preferred.
  • Immediately available for an on-site, full-time engagement

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