Site Quality Director – GMP & Radiopharma Scale-Up

AdvanCell; Andover (MN); On-site; USD 175,000 - 250,000; Full time

Job summary

AdvanCell seeks a Director, Site Quality to lead the QA and QC functions at the Andover manufacturing site. You will drive the Quality Management System, ensure GMP compliance, and oversee release and distribution of radiopharmaceutical products.

You will partner across Manufacturing, Regulatory Affairs, MSAT, Supply Chain, Engineering, and External partners to build a scalable, compliant quality organization as the site progresses from clinical to commercial operations.

Qualifications

• 12+ years of progressive experience in pharmaceutical, biotechnology, radiopharmaceutical, biologics, sterile manufacturing, or related regulated industries.
• 7+ years of leadership experience managing Quality Assurance, Quality Control, or site quality organizations.
• GMP Quality Management Systems experience in regulated manufacturing environments.
• Experience leading regulatory inspections, including preparation, hosting, response management, and closure of observations.

Responsibilities

• Lead QA and QC teams, establish and execute site Quality strategy and roadmap.
• Oversee QMS including deviations, CAPA, change control, investigations, and risk management.
• Ensure Regulatory Compliance and inspection readiness for FDA and other regulators.
• Provide independent Quality oversight of radiopharmaceutical product manufacture, testing, release, storage, and distribution.
• Manage supplier and external partner quality oversight and contracts.

Skills

Quality leadership

Regulatory compliance

GMP knowledge

Quality Management Systems

Risk management

Auditing

Cross-functional leadership

Deviations & CAPA

Education

Bachelor’s degree in science

Advanced degree preferred

Tools

LIMS

ERP systems

Electronic batch records

Job description

AdvanCell seeks a Director, Site Quality to lead the QA and QC functions at the Andover manufacturing site. You will drive the Quality Management System, ensure GMP compliance, and oversee release and distribution of radiopharmaceutical products.

You will partner across Manufacturing, Regulatory Affairs, MSAT, Supply Chain, Engineering, and External partners to build a scalable, compliant quality organization as the site progresses from clinical to commercial operations.