Associate Director, External Quality – Radiopharma

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

Benefits offered by this job

401(k) plan

Paid vacation and holidays

Health benefits

Equity-based long-term incentive

Job summary

Fusion Pharmaceuticals, a member of the AstraZeneca Group, seeks an Associate Director, External Quality for its Boston, MA hybrid site. You will oversee external manufacturing partners, testing labs, and suppliers to ensure cGMP compliance and high-quality products across drug substances and products.

The role leads risk management, investigations, CAPA, and regulatory readiness, reporting to the Head of Radiopharmaceutical Quality.

Qualifications

• Bachelor’s degree in science required; advanced degree preferred.
• 10–12 years in pharma/biotech quality or manufacturing with external partners.
• Strong knowledge of cGMP for drug substance/product and ICH guidelines; familiarity with GDP.

Responsibilities

• Provide strategic and operational quality oversight for CDMOs/CMOs, labs, and key suppliers.
• Ensure partner adherence to cGMP/cGDP/cGLP and data integrity; maintain quality agreements.
• Guide validation/qualification, technology transfers, and change management.
• Lead risk assessments (FMEA/ICH Q9) to identify and mitigate risks.
• Oversee quality investigations and CAPA with timely closure and verification.
• Support regulatory inspections and submissions; ensure inspection readiness.
• Define supplier benchmarks and monitor governance; drive continuous improvement.
• Collaborate with Operations, Supply Chain, CMC, and Procurement on quality matters.

Skills

Quality oversight

Risk management

CAPA investigations

Regulatory readiness

Cross-functional leadership

Vendor management

Communication

Travel

Education

Bachelor’s degree in pharmacy/chemistry/biology/engineering

Tools

Electronic QMS

Quality documentation systems

Job description

Fusion Pharmaceuticals, a member of the AstraZeneca Group, seeks an Associate Director, External Quality for its Boston, MA hybrid site. You will oversee external manufacturing partners, testing labs, and suppliers to ensure cGMP compliance and high-quality products across drug substances and products.

The role leads risk management, investigations, CAPA, and regulatory readiness, reporting to the Head of Radiopharmaceutical Quality.