Associate Director, External Quality

AstraZeneca • Boston, MA

20h • Hybrid

About The Position

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next generation radio conjugates (RCs) as precision medicines. Fusion has multiple pipeline programs entering early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support these programs, Fusion has a fully operational radio conjugate manufacturing facility. It is brand new and GMP compliant to meet the demand for our growing pipeline of RCs. The Role: AD, External Quality – Radio Conjugates is accountable for end-to-end Quality oversight of external manufacturing partners, contract development and manufacturing organizations (CDMOs), suppliers, and testing laboratories supporting commercial and/or late-stage clinical products. The role ensures products and processes supplied by external partners meet applicable cGxP requirements, marketing authorization commitments, and company standards. This leader drives proactive quality risk management, addressing customer concerns and resolution, and continuous improvement across the external network. This position will report to the Head of Radiopharmaceutical Quality.

Requirements

• Bachelor’s degree in pharmacy, Chemistry, Biology, Engineering, or related scientific field required; advanced degree or equivalent experience preferred.
• 10–12 years in pharmaceutical/biotech Quality or Manufacturing with significant experience overseeing external manufacturing/testing partners.
• Demonstrated leadership in commercial and/or late-stage clinical operations.
• Strong knowledge of cGMP for drug substance and drug product, ICH guidelines (Q7, Q8–Q10, Q12), and data integrity principles; familiarity with GDP for distribution oversight.
• Experience with biologics and/or small molecules; cell/gene therapy experience is a plus depending on portfolio.
• Hands-on experience with deviation/investigation management, CAPA, change control, complaints/recalls, validation, stability, and batch disposition.
• Comfortable with electronic QMS and quality documentation systems.
• Proven track record leading external audits and supporting or hosting health authority inspections with successful outcomes.
• Experience in technology transfers, PPQ, method transfers, cleaning/process validation, and control strategy implementation.
• Proficiency in risk assessment tools and using data/metrics to drive decisions and continuous improvement.
• Strong influencing and relationship-building skills with external partners; crisp written and verbal communication; ability to lead through ambiguity, prioritize effectively, and escalate with clarity.
• Vendor negotiation and conflict resolution experience beneficial.

Nice To Haves

• Prior radio conjugate experience
• Prior responsibility for multiple CMOs/CDMOs across regions and modalities (DS, DP, packaging/labeling).
• Experience integrating quality considerations into sourcing and contracting; drafting/negotiating Quality Agreements.
• Familiarity with serialization/traceability, Annex 1 for sterile manufacturing (if applicable), and computerized system compliance (CSV/CSA).
• Knowledge of environmental monitoring, contamination control strategies, and aseptic processing for sterile products.
• Exposure to statistical sampling, SPC, and continued process verification.

Responsibilities

• Provide strategic and operational Quality oversight for assigned CDMOs/CMOs, testing labs, and critical suppliers across drug substance, drug product, packaging/labeling, and distribution.
• Establish quality governance, performance metrics, and relationship management routines.
• Ensure partner adherence to cGMP/cGDP/cGLP, ICH, and relevant regional regulations (e.g., FDA, EMA, MHRA, PMDA).
• Maintain robust Quality Agreements and ensure effective implementation of the company’s Quality Management System elements at partners (deviation/CAPA, change control, complaints, recalls, batch release, training, data integrity, and document control).
• Guide validation/qualification (process, cleaning, methods, equipment), technology transfers, and change management.
• Review/approve master and completed batch records, specifications, method transfers, and validation protocols/reports.
• Lead risk assessments (FMEA, HACCP, ICH Q9 principles) to identify and mitigate quality and supply risks.
• Drive proactive detection and prevention strategies, trend analysis, and management reviews.
• Oversee and approve quality investigations for deviations, OOS/OOT, complaints, and stability issues from partners.
• Ensure high-quality root cause analysis and effective, sustainable CAPAs with timely closure and verification of effectiveness.
• Ensure partners are inspection ready.
• Lead or support health authority inspections and partner audits; manage responses, commitments, and follow-up actions.
• Contribute to regulatory submissions (CMC quality sections) and post-approval changes.
• Define and monitor Supplier benchmarks (right-first-time, deviation rate, cycle times, complaint rate, timely CAPA, audit/inspection outcomes).
• Advance significant quality or supply risks through internal governance and lead cross-functional resolution.
• Partner closely with Technical Operations, Manufacturing, Supply Chain, CMC, Procurement, and Quality Control to ensure reliable supply and compliant operations.
• Provide quality input to sourcing decisions, business continuity, and network strategy.
• Champion guidelines, digital/analytics enablement, and quality culture across the external network.
• Drive simplification and standardization of processes to improve compliance and efficiency.
• Provide matrix leadership to site-facing quality teams and subject matter experts; mentor partners on expectations and standards.

Benefits

• Great People want to Work with us! Find out why: GTAA Top Employer Award for 11 years Top 100 Employers Award Canada’s Most Admired Corporate Culture Learn more about working with us in Canada View our YouTube channel Are you interested in working at AZ, apply today!
• AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
• AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respects of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].
• Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
• If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
• AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior