Senior QA Director - Site Leader, Regulatory Readiness

ADP, Inc.; Rochester (MN); Hybrid; USD 190,000 - 250,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Nucleus RadioPharma is seeking a Senior Director of Quality Assurance to lead the Quality function at the Rochester facility. This hands-on leader will oversee QA, sterility assurance, laboratory operations, batch disposition, and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

As a member of the Site Leadership Team, this role requires strong independent judgment, risk-based decision making, and the ability to drive a culture of quality across

Qualifications

• Bachelor's degree in a scientific field as listed.
• Minimum 12 years in quality with leadership in a manufacturing setting.
• Experience leading audits/inspections by FDA or health authorities.
• Strong knowledge of cGMP, data integrity, and ICH guidelines.
• Experience with sterile radiopharmaceutical manufacturing and Aseptic processing.

Responsibilities

• Define QA operating model, staffing, and interfaces with QA, QC, Operations, MSAT, Engineering, Regulatory, and Supply Chain.
• Approve or reject components, materials, procedures, investigations, and batches; pause manufacturing when needed.
• Oversee cGMP operations, material receipt and release, aseptic processing, radiolabeling, and lab operations.
• Lead QA systems improvement including deviations, investigations, CAPAs, change control, complaints, recalls, and document control.
• Establish year-round inspection readiness with risk-based audit plans and mock inspections.
• Serve as senior Rochester QA partner for audits, regulatory responses, and technology transfer support.
• Collaborate with clients to provide QA leadership for process validation, cleaning validation, stability, and launch readiness.
• Define Quality roadmap as part of Site Leadership Team with executive visibility into performance and risk.
• Develop and coach a technically strong QA team and promote a speak-up culture.
• Set annual QA objectives, resources, and budget aligned to clinical and future commercial commitments.

Skills

Leadership

Quality systems

cGMP

FDA inspections

Sterile manufacturing

Aseptic processing

Radiopharmaceutical manufacturing

Data integrity

Process improvement

Regulatory affairs coordination

Education

Bachelor's degree in pharmacy, chemistry, biology, biochemistry, or related

Tools

eQMS

CAPA system

Documentation control

Job description

Nucleus RadioPharma is seeking a Senior Director of Quality Assurance to lead the Quality function at the Rochester facility. This hands-on leader will oversee QA, sterility assurance, laboratory operations, batch disposition, and inspection readiness for clinical and future commercial radiopharmaceutical manufacturing.

As a member of the Site Leadership Team, this role requires strong independent judgment, risk-based decision making, and the ability to drive a culture of quality across