Qualification Manager

Objective

As the Qualification Manager for Perspective Therapeutics in Bloomingdale, IL, you will be leading, executing, and managing all qualification, commissioning, and validation activities for a brand‑new start‑up GMP‑compliant Radioligand Therapy (RLT) pharmaceutical manufacturing facility. You will be responsible for ensuring that all facilities, utilities, equipment, computerized systems, and production software are designed, installed, tested, and maintained in good compliance with global regulatory requirements (cGMP, FDA, ISO, EU, etc.).

You will establish a CQV (Commissioning, Qualification, Validation) strategy for all equipment and systems entering the site, author governing documents (such as a Validation Master Plan and equipment specific SOPs), manage vendors and internal stakeholders, and ensure successful transition from project execution to GMP operations.

The Qualification Manager will act as lead/focal point for processing and communication with other departments while the site works towards production. As this position will amass all equipment and systems SME knowledge, they will spearhead the Engineering department as the site grows and matures. Also, this position will be a key role in providing support for internal and FDA audits.

• Facility Start‑Up: Lead all qualification start‑up activities, including production, quality, safety, and facility equipment and systems to support GMP radiopharmaceutical manufacturing. Establish Engineering infrastructure, standard operating procedures, and workflows required to transition from start‑up to steady‑state manufacturing. Support initial regulatory inspections and audits associated with facility start‑up and first product launches.
• CQV Strategy: Work with Project Managers and stakeholders to define and align qualification strategies with equipment lead times to ensure continuous CQV activities are being executed while adhering to aggressive timelines.
• Leadership & Management: Lead the Illinois Engineering and Facilities team, focusing primarily on qualification activities, to ensure optimal installation, operation, and performance of equipment and systems, while implementing work streams to ensure their longevity.
• Maintenance & Calibration: Understand equipment and regulatory requirements to ensure equipment and systems are handed over in ready‑to‑use state. Provide subject matter expertise for production equipment and systems, utilities, EMS/BMS, and HVAC systems.
• Compliance & Validation: Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements through effective management of validation, change controls, CAPA, and deviation activities. Lead the site through regulatory inspections with zero observations. Author and execute Change Controls through the Quality Management System. Create and revise SOP documentation governing operation and facility practices.
• Qualification Improvements: Develop and implement robust qualification, commissioning, and validation programs. Drive continuous improvement initiatives using lean manufacturing and Six Sigma methodologies to optimize efficiency.
• Cross‑Functional
  
  Collaboration:
  
  Represent Engineering & Facilities on the Site Leadership Team. Collaborate with key internal stakeholders such as Production, Quality, Environment Health & Safety, to support site operations in resolving engineering challenges, and ensuring timely project execution.
• Vendor Management: Work closely with vendors for procurement, installation, commissioning, and validation of new equipment and systems, ensuring alignment with site objectives and compliance standards. Trainer and access management of third‑party contractors and vendors.
• Safety & Compliance: Ensure that all engineering and facilities activities meet OSHA, DEC, EPA, fire codes, and building codes. Work with established safety professionals to develop safety programs and ensure their adherence (such as LOTO, Permit‑to‑Work, etc).
• Team Development: Foster a highly engaged workforce by mentoring, developing, and evaluating the performance of engineering and facilities team members. Build strong internal talent pipelines and ensure…