Site Quality Director - GMP Radiopharma Leader

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

Job summary

AdvanCell is seeking a Director, Site Quality to serve as the senior quality leader for the Andover manufacturing site. You will provide strategic and operational leadership to ensure the effectiveness of the site Quality Management System and compliance with GMP, regulatory, radiation safety, and corporate requirements.

The role oversees QA and QC functions, batch release, QC labs, validation oversight, supplier quality, inspection readiness, and continuous improvement.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Engineering, Life Sciences, or a related scientific discipline.
• 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.
• Proven experience leading GMP Quality Management Systems within regulated manufacturing environments.
• Strong knowledge of global GMP regulations and quality standards (FDA, EMA, PIC/S, ICH).
• Experience leading regulatory inspections, including preparation, hosting, response management, and closure of observations.

Responsibilities

• Provide strategic and operational leadership to ensure the effectiveness of the site QMS and compliance with regulatory requirements.
• Lead, develop, and mentor QA and QC teams, building a culture of quality and continuous improvement.
• Oversee QA/QC, batch disposition and release, QC laboratory operations, validation oversight, and supplier quality.
• Ensure inspection readiness and timely responses to regulatory observations.
• Partner with cross-functional teams to scale the quality organization with site growth.

Skills

Quality leadership

GMP knowledge

Regulatory inspections

Quality management systems

Risk management

Cross-functional leadership

Education

Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Engineering, Life Sciences, or related field

Tools

LIMS

ERP

Job description

AdvanCell is seeking a Director, Site Quality to serve as the senior quality leader for the Andover manufacturing site. You will provide strategic and operational leadership to ensure the effectiveness of the site Quality Management System and compliance with GMP, regulatory, radiation safety, and corporate requirements.

The role oversees QA and QC functions, batch release, QC labs, validation oversight, supplier quality, inspection readiness, and continuous improvement.