Qualification Manager

Perspective Therapeutics•Chicago, IL

2d•Onsite

About The Position

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.

Requirements

Bachelor’s degree (required) in Chemical, Mechanical, Industrial Engineering, or related field
Minimum of 7 years of experience in an engineering role, with at least 3 years in a leadership position, within the pharmaceutical or life sciences industry
Proven expertise in commissioning, qualification, validation, preventive maintenance, calibration, automation, and compliance with FDA and GMP standards
Experience with project management, including design, build, and validation of manufacturing and packaging lines
Strong knowledge of BMRAM, EMS, BMS, Salesforce, and other relevant engineering management systems
Experience with MS Office Suite required
Strong interpersonal skills and the ability to communicate effectively verbally and via email
Understanding of project accounting, project planning, execution and startup
Experience with equipment to support GMP and non-GMP operations, packaging equipment and engineering system controls (e.g. HVAC systems, utility systems)
Familiarity with Computerized Maintenance Management Systems
Knowledge of safety procedures for working in a hazardous environment (chemical or radiological) as demonstrated through prior experience
Adherence to project timelines may require overtime work on evenings, weekends, and/or holidays.
Ability to travel up to 15% domestically. (Will be based onsite in Illinois).
Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
Mechanical aptitude required; manual dexterity for manipulating small items; Ability to safely lift and move materials up to 50 pounds, with or without reasonable accommodation and to handle frequent crawling, stooping, crouching, and kneeling
Must be willing to wear a variety of personal protective equipment
May be required to sit or stand for long periods of 8+ hours a day while performing duties
Willingness to complete safety training within allotted timeframes, and work in a team-based environment

Nice To Haves

Direct experience with radiopharmaceutical or RLT facilities strongly preferred
Lean Six Sigma Green Belt or equivalent certification preferred.
Knowledge of cGMP requirements preferred

Responsibilities

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 workstreams 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 continuous learning and development. Define training programs for the Engineering team.
Equipment & Systems: Familiarize yourself with the following types of equipment and systems: Process gasses (CA & N2), HVAC Systems (diffusers, VAVs, EDHs, humidifiers, chillers), Cleanrooms, Power Generators and UPSs, Calibration Standards, Product Synthesizers, Lead-Shielded Isolators, Dispensing Systems, Dose Calibrator, Visual Inspection machines, Radiation monitors, Particle Counters & Air Samplers, BSCs & Fume Hoods, Refrigerators, Freezers, Incubators, CMMS (BMRAM), BMS, EMS, Production software, Access Controls, etc.
Documentation: Author supporting documentation for qualification activities: URSs, FRSs, DSs, FAT/SAT Protocols, IQ/OQ/PQ Protocols, Traceability Matrices, related SOPs
Other: Provides support for internal and FDA audits.