Full-Time
Associate Director
External Quality
Posted on 9/14/2026
AstraZeneca
10,001+ employees
Global pharmaceutical company developing prescription medicines
No salary listed
Boston, MA, USA
Hybrid
Three days on-site per week required.
Bachelor's, Master's
 Biology & Biotech (1) |
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- A bachelor's degree in pharmacy, chemistry, biology, engineering, or a related scientific field is required.
- Ten to twelve years of experience in pharmaceutical or biotechnology Quality or Manufacturing, including significant experience overseeing external manufacturing and testing partners, is required.
- Demonstrated leadership in commercial and/or late-stage clinical operations is required.
- Strong knowledge of current Good Manufacturing Practices for drug substance and drug product, International Council for Harmonisation guidelines Q7, Q8–Q10, and Q12, and data integrity principles is required.
- Familiarity with Good Distribution Practices for distribution oversight is required.
- Experience with biologics and/or small molecules is required.
- Hands-on experience with deviation and investigation management, corrective and preventive actions, change control, complaints and recalls, validation, stability, and batch disposition is required.
- Experience with electronic quality management systems and quality documentation systems is required.
- A proven track record leading external audits and supporting or hosting health authority inspections with successful outcomes is required.
- Experience in technology transfers, process performance qualification, method transfers, cleaning and process validation, and control strategy implementation is required.
- Proficiency in risk assessment tools and using data and metrics to drive decisions and continuous improvement is required.
- Strong influencing and relationship-building skills with external partners are required.
- Experience leading through ambiguity, prioritizing effectively, and escalating with clarity is required.
- More than 20–30% travel is required.
- Provide strategic and operational Quality oversight for assigned contract development and manufacturing organizations, contract manufacturing organizations, testing laboratories, and critical suppliers across drug substance, drug product, packaging and labeling, and distribution.
- Establish quality governance, performance metrics, and relationship-management routines.
- Ensure external partners adhere to current Good Manufacturing Practices, current Good Distribution Practices, current Good Laboratory Practices, International Council for Harmonisation guidelines, and relevant regional regulations, including the Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, and Pharmaceuticals and Medical Devices Agency.
- Maintain Quality Agreements and ensure effective implementation of company Quality Management System elements at external partners, including deviation and corrective and preventive action management, change control, complaints, recalls, batch release, training, data integrity, and document control.
- Guide process, cleaning, method, and equipment validation and qualification, technology transfers, and change management.
- Review and approve master and completed batch records, specifications, method transfers, and validation protocols and reports.
- Lead risk assessments using Failure Mode and Effects Analysis, Hazard Analysis and Critical Control Points, and International Council for Harmonisation 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, out-of-specification and out-of-trend results, complaints, and stability issues from external partners.
- Ensure high-quality root-cause analysis and effective, sustainable corrective and preventive actions with timely closure and verification of effectiveness.
- Ensure external partners are inspection-ready.
- Lead or support health authority inspections and partner audits, and manage responses, commitments, and follow-up actions.
- Contribute to regulatory submissions involving Chemistry, Manufacturing, and Controls quality sections and post-approval changes.
- Define and monitor supplier benchmarks, including right-first-time performance, deviation rate, cycle times, complaint rate, timely corrective and preventive actions, and audit or inspection outcomes.
- Advance significant quality or supply risks through internal governance and lead cross-functional resolution.
- Partner with Technical Operations, Manufacturing, Supply Chain, Chemistry, Manufacturing, and Controls, 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 and 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 external partners on expectations and standards.
- Equivalent experience in place of the required advanced degree.
- Vendor negotiation and conflict-resolution experience.
- Prior radio conjugate experience.
- Prior responsibility for multiple contract manufacturing organizations and contract development and manufacturing organizations across regions and modalities, including drug substance, drug product, and packaging and labeling.
- Experience integrating quality considerations into sourcing and contracting and drafting or negotiating Quality Agreements.
- Familiarity with serialization and traceability, Annex 1 for sterile manufacturing when applicable, and computerized system compliance, including computer system validation and computer software assurance.
- Knowledge of environmental monitoring, contamination control strategies, and aseptic processing for sterile products.
- Exposure to statistical sampling, statistical process control, and continued process verification.
AstraZeneca develops and markets prescription medicines and vaccines for global health, focusing on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells to treat diseases or prevent infections, using small-molecule drugs, biologics, and vaccines. The company differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D with collaborations to move from discovery to patient access across multiple therapeutic areas. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines worldwide.
Company Size
10,001+
Company Stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913
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Simplify's Take
What believers are saying
- EU approved Enhertu plus pertuzumab on September 1, 2026, unlocking another breast-cancer line.
- Amgen and AstraZeneca’s DeLLphi-305 met overall-survival goals for Imdelltra plus Imfinzi.
- AstraZeneca committed £300 million in April 2026 to Cambridge and Macclesfield expansion.
What critics are saying
- Reuters on August 17, 2026 said AstraZeneca ended volrustomig’s lung-cancer trial after futility.
- China indicted Leon Wang and AstraZeneca’s local unit in February 2026; trial risk persists.
- Forxiga faces patent losses in Poland, Portugal, Australia, and 2027 generic-launch pressure.
What makes AstraZeneca unique
- AstraZeneca’s 2026 cancer franchise spans Imfinzi, Tagrisso, Enhertu, and Datroway globally.
- Its UK-Sweden operating base supports Cambridge and Macclesfield R&D plus manufacturing.
- Daiichi Sankyo and Amgen partnerships broaden AstraZeneca’s reach without full internal capital burden.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
Paid Vacation
Paid Holidays
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 2%1 year growth
↑ 2%2 year growth
↑ 4%Jim Cramer stated on Mad Money that he is not investing in AstraZeneca, comparing it to Novartis and expressing concerns about missed clinical trials. He believes the company's COPD programme is insufficient to change his view. AstraZeneca reported second-quarter revenue of $15.38 billion, up 6.4% year-on-year, with adjusted earnings per share of $2.63 beating estimates. Growth was driven by oncology and rare disease treatments, offsetting generic competition. However, the company faces significant challenges. The drug anselamimab failed its primary endpoint in a Phase III trial, whilst datopotamab deruxtecan delivered mixed results in lung cancer studies. AstraZeneca's blockbuster drug Farxiga will face a 68% Medicare price reduction from 2026 under the Inflation Reduction Act. The company also contends with regulatory investigations in China involving senior executives.
Amgen and AstraZeneca announced positive results from the phase III DeLLphi-305 study evaluating Amgen's Imdelltra (tarlatamab) combined with AstraZeneca's Imfinzi (durvalumab) as first-line maintenance treatment for extensive-stage small-cell lung cancer (ES-SCLC). The study met its primary endpoint of overall survival and key secondary endpoint of progression-free survival, with no new safety concerns identified. ES-SCLC affects approximately 195,000 people globally. If approved, the combination would compete with Jazz Pharmaceuticals' Zepzelca plus Roche's Tecentriq, which received FDA approval in October 2025. Imdelltra, approved in 2024 for ES-SCLC progression after platinum-based chemotherapy, generated $546 million in global sales during the first half of 2026, up from $215 million in the prior-year period.
Drug giant AstraZeneca has agreed to buy KuDOS Pharmaceuticals, a UK biotech company, for $210mn (£120m).
AstraZeneca shares declined approximately 0.7% to $161.51 despite positive late-stage trial results for Imfinzi in treating extensive-stage small-cell lung cancer. The 563-patient DeLLphi-305 trial met its primary overall-survival goal when Imfinzi was combined with Amgen's Imdelltra, also improving progression-free survival and response rates with no new safety concerns. However, the companies have not released numerical survival data, leaving investors unable to assess the treatment's competitive strength. Imfinzi generated $6.06 billion in 2025, whilst oncology represented approximately 46% of AstraZeneca's $30.7 billion first-half 2026 revenue. The shares now trade 10.72% below their $180.91 valuation estimate. AstraZeneca must share economics with Amgen and demonstrate that the treatment's added complexity can convert into meaningful sales growth.
First Oncology Summit in Lebanon hosted by AstraZeneca brings together regional experts to advance the Future of Cancer Care. September 7, 2026 Beirut, 7 September 2026: The first Oncology Summit hosted by AstraZeneca in Lebanon under the theme "Leading the Future in Cancer Care" brought together leading oncology experts from Lebanon and Libya, alongside international faculty members, for two days of scientific exchange and collaboration focused on advancing cancer care and improving patient outcomes. The summit featured discussions on evolving standards of care, emerging scientific advances, and multidisciplinary approaches across lung cancer, gastrointestinal cancers, breast cancer, and ovarian cancer. "Scientific meetings such as this are essential to advancing oncology practice," said Dr. Arafat Tfayli, President of the Committee Responsible for Implementing Lebanon's National Cancer Control Plan. "They allow healthcare professionals to exchange experiences, discuss the latest evidence, and learn from regional and international experts. By strengthening collaboration and sharing knowledge, we can continue to elevate the quality of care available to patients across our region." "The challenges we face in cancer care are shared across many countries, and so too are the opportunities for progress," said Dr. Abdelmnam Elbarathi, Director of Tripoli Cancer Center, speaking on behalf of the Lybian delegation. "Bringing together experts from Libya and Lebanon creates meaningful opportunities for collaboration, learning, and professional exchange that can ultimately contribute to better care for patients. We look forward to strengthening these connections and continuing to work together to advance oncology practice throughout the region." The landmark event underscored AstraZeneca's commitment to supporting the oncology community through innovation, science, and partnerships, while reinforcing Lebanon's role as a regional platform for medical excellence and scientific dialogue. "Lebanon has long been recognized for its medical expertise, and we are proud to contribute to its role as a hub for scientific leadership and innovation," said Agnar Aboujaoude, Country Director, AstraZeneca Lebanon, who emphasized the power of collaboration in shaping the future of oncology care. "We are proud to bring together distinguished oncology experts from Lebanon, Libya, and the international scientific community around a shared purpose: improving the lives of patients with cancer. By fostering scientific exchange and regional collaboration, we can help accelerate the adoption of best practices, strengthen healthcare ecosystems, and ultimately bring new hope to patients and their families." The summit provided a platform for healthcare professionals to exchange knowledge, review emerging evidence, discuss real-world clinical experiences, and explore innovative approaches that are helping redefine cancer care worldwide. Throughout the discussions, participants examined the evolving oncology landscape and the opportunities to improve outcomes through earlier diagnosis, precision medicine, multidisciplinary care, and continued scientific advancement. "At AstraZeneca, our ambition is to eliminate cancer as a cause of death," said Mark Farid, Oncology Commercial Director for Near East & Maghreb at AstraZeneca, highlighting the company's long-term commitment to transforming cancer care through scientific innovation. "We continue to invest in one of the industry's broadest oncology portfolios and pipelines, advancing innovative science across multiple tumour types and treatment modalities. Through collaboration with healthcare professionals, researchers, and healthcare systems, we are working to transform outcomes and bring patients closer to a future where cancer can be detected earlier, treated more effectively, and, ultimately, cured." About AstraZeneca: AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.