Associate Director, External Quality – Radiopharma

AstraZeneca; Boston (MA); Hybrid; USD 135,000 - 203,000; Full time

Job summary

Fusion Pharmaceuticals, a member of the AstraZeneca Group, seeks an Associate Director, External Quality in Boston, MA. The Hybrid role requires oversight of external partners across CDMOs/CMOs, ensuring cGMP/cGDP/cGLP compliance and continuous improvement.

The role reports to the Head of Radiopharmaceutical Quality and demands strong leadership, collaboration with multiple functions, and periodic travel (20–30%). 135k–203k USD base pay with incentive opportunities.

Qualifications

• 10–12 years in pharmaceutical/biotech Quality or Manufacturing with external partners.
• Strong knowledge of cGMP for drug substance and drug product; familiarity with GDP for distribution oversight.
• Experience leading external audits and health authority inspections.

Responsibilities

• External Partner Oversight for CDMOs/CMOs, labs and suppliers with governance metrics.
• Ensure partner adherence to cGMP/ICH and regional regs; maintain Quality Agreements and QMS elements.
• Lead validation/qualification, technology transfers and change management.
• Lead risk assessments to identify and mitigate quality and supply risks; drive CAPAs and investigations.
• Support regulatory readiness and regulatory submissions (CMC quality sections).
• Define and monitor supplier benchmarks and drive cross-functional resolution.

Skills

Leadership

Communication

Vendor negotiation

Influencing skills

Relationship-building

Travel willingness

Education

Bachelor’s degree in pharmacy, Chemistry, Biology, Engineering, or related field

Advanced degree or equivalent experience preferred

Job description

Fusion Pharmaceuticals, a member of the AstraZeneca Group, seeks an Associate Director, External Quality in Boston, MA. The Hybrid role requires oversight of external partners across CDMOs/CMOs, ensuring cGMP/cGDP/cGLP compliance and continuous improvement.

The role reports to the Head of Radiopharmaceutical Quality and demands strong leadership, collaboration with multiple functions, and periodic travel (20–30%). 135k–203k USD base pay with incentive opportunities.