Executive QA Leader - cGMP, Inspections & Compliance

Evolving Solution Services; Rochester (MN); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Relocation assistance

Paid time off

Job summary

Nucleus RadioPharma is seeking a Senior Director of Quality Assurance for its Rochester, MN facility. This hands-on leader will oversee QA, sterility, and laboratory operations, ensuring cGMP compliance and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

As a member of the Site Leadership Team, you will drive quality culture, coach leaders, and manage QA budget, risk, and strategic priorities with a focus on patient safety and data integrity.

Qualifications

• 12+ years in quality with 10+ years leadership and 5+ years at a senior site leadership level.
• Experience with sterile drug manufacturing, aseptic processing, contamination control, and microbiology/environmental monitoring programs, including batch release.
• Experience hosting FDA or health authority inspections and leading sponsor or customer audits.
• Strong knowledge of US CGMP (21 CFR Parts 210, 211, 212, 11) and ICH guidance; data integrity awareness.

Responsibilities

• Lead the Rochester QA organization as the site’s primary Quality decision-maker and interface with QC, Operations, MSAT, Engineering, Validation, Regulatory Affairs, and Supply Chain.
• Exercise independent authority to approve or reject components, materials, procedures, investigations, and product batches; pause manufacturing when needed.
• Provide end-to-end QA oversight of cGMP operations including aseptic processing, radiolabeling, sterile filling, and lab operations; ensure records are complete and reviewed before disposition.
• Own the performance and continuous improvement of Quality systems (deviations, investigations, CAPAs, change control, complaints, recalls, document control, training, supplier quality, eQMS).
• Lead annual audit plans and inspection readiness, including mock inspections and playbooks; coordinate with customers and FDA health authorities.

Skills

Quality leadership

Regulatory knowledge

cGMP

FDA inspections

Risk-based decisions

Quality systems

Team building

Communication skills

Onsite presence

Education

Bachelor's degree in relevant science

Advanced degree preferred

Tools

eQMS

Job description

Nucleus RadioPharma is seeking a Senior Director of Quality Assurance for its Rochester, MN facility. This hands-on leader will oversee QA, sterility, and laboratory operations, ensuring cGMP compliance and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

As a member of the Site Leadership Team, you will drive quality culture, coach leaders, and manage QA budget, risk, and strategic priorities with a focus on patient safety and data integrity.