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Head of Sterility Assurance and Contamination Control
BP70 Alexion Pharma Intl Ops Limited Company
Source: Headcount Labs · original listing ↗
Job data: Headcount Labs, ODbL 1.0. Job descriptions belong to their employers.
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About this role
Introduction to role: Are you ready to set the global standard for sterility assurance and contamination control so patients receive safe medicines without interruption? In this senior leadership role, you will shape how sterility assurance is practised across a worldwide network producing therapies for people with rare diseases, safeguarding both patient safety and reliable supply. You will own the global strategy for sterility assurance and contamination control, harmonizing standards and elevating technical excellence across Drug Substance, Drug Product and Combination Product manufacturing at internal sites and CDMOs. Reporting to the Executive Director of Technical Operations, you will embed sterility assurance within the Pharmaceutical Quality System, strengthen oversight of microbial and aseptic risks, and ensure data-driven, inspection-ready systems that stand up to the toughest scrutiny. Will you turn data into foresight, transforming environmental monitoring signals and deviation trends into proactive prevention? As a strategic partner to QA, QC and Site Quality leaders, you will guide site-based microbiologists and aseptic processing specialists through a matrixed governance model—building capability, enabling independent quality decisions, and fostering a culture where scientific rigor and speaking up drive continuous improvement. Accountabilities: - Global SA&CC Strategy and Standards: Set and own the global sterility assurance and contamination control strategy, harmonized standards and technical positions; ensure consistent application and measurable outcomes across the network. - Contamination Control Strategy (Annex 1): Define the technical content and structure for integrated, science- and risk-based CCS documents; jointly review and approve site CCS with QA, keep them current and compliant, and verify effectiveness via periodic reviews. - Aseptic Processing Technical Excellence: Establish network standards for aseptic design and operation, including cleaning and disinfection, sporicidal programs, cleanroom design and qualification, EM programs, gowning and personnel qualification, material and equipment transfer, and sterilization validation; provide input on HVAC, utilities and facility design. - Aseptic Process Simulation (Media Fills): Own the global APS strategy and technical standards to ensure simulations provide robust proof of control and continued aseptic capability. - Contamination Event Response and Investigations: Coordinate responses to contamination and sterility assurance events; lead complex investigations and root cause analysis; define effective CAPA; assess product impact to support QA batch disposition; escalate significant issues through quality governance. - Quality Risk Management and PQS Integration: Apply ICH Q9 tools (e.g., FMEA, contamination risk mapping); trend EM, deviation and investigation data to identify emergent risks; define SA&CC metrics and KPIs for management review; own SA&CC procedures within document control; provide SA&CC assessments for change control; assure data integrity and GMP compliance of EM and microbiological data; support self-inspections. - Regulatory Intelligence and Inspection Readiness: Monitor and interpret evolving global expectations for aseptic processing; act as lead technical SME in inspections, audits and health authority interactions; ensure timely closure of observations; contribute SA&CC content for submissions and responses with Regulatory Affairs. - NPI and Tech Transfer: Serve as a standing member of NPI/Tech Transfer steering; embed contamination control by design in new products and facilities; align on risk assessments and validation expectations before transfer, qualification and release. - Innovation and Microbial Methods: Set strategy and standards for microbiological methods; introduce rapid microbial methods, barrier/isolator technologies, automation and advanced analytics for contamination-signal detection and EM trending under robust validation, change control, data integrity and human-oversight frameworks. - People Leadership and Capability: Mentor and coach site microbiology and aseptic teams; build a talent pipeline in scarce aseptic expertise; upskill cross-functional teams in microbiological risk and aseptic behaviors; cultivate a culture of prevention, accountability and continuous improvement. Essential Skills/Experience: - Qualification: Bachelor's degree in microbiology, biology or a related life science. - Experience: 15+ years in sterility assurance, aseptic processing, contamination control or industrial microbiology in biopharma within a GMP quality or technical operations environment. - Functional leadership: Prior leadership of an SA&CC function or equivalent at comparable scale, with proven ability to direct, mentor and develop teams. - Regulatory expertise: Deep expertise in evolving global aseptic processing and sterile drug regulatory expectations, with a track record of authoring and defending CCSs and acting as SME in health authority inspections. - Technical breadth: Deep knowledge of aseptic processing, cleanroom classification, HVAC principles, sterilisation technologies, EM, APS and quality risk management; experience with combination product aseptic processing and container-closure integrity. - Microbial methods: Broad expertise in microbiological methods used in sterile manufacturing, including method validation. - Investigations: Experience leading sterility failure and contamination investigations, including root cause analysis, product impact assessment and CAPA effectiveness. - Quality systems and GMP: Strong working knowledge of GMP and the PQS (deviation, CAPA, change control, quality risk management, data integrity, quality metrics and management review). - Influence and communication: Strong influencing skills at the boundary between Quality and Technical Operations, bridging science and operations with a proactive, prevention-focused approach through matrixed influence in a global governance and standards-setting role. - Global and project experience: Demonstrated experience establishing or governing sterility assurance standards across multiple sites and/or external manufacturing partners, and leading SA&CC for facility design, qualification and start-up of aseptic operations. Desirable Skills/Experience: - Master's degree or PhD in microbiology or a related life science. - Experience in Quality Assurance or Quality Control roles, or in CDMO quality oversight. - Understanding of AI and advanced analytics applied to EM and microbial data, and awareness of the emerging regulatory landscape for AI/ML in microbial control. Why AstraZeneca: Join a company that pairs the autonomy and pace of a pioneering biotech with the scale, resources and staying power of a global biopharma. Here, unexpected teams sit around the same table—Quality, Technical Operations, Data Science and Manufacturing—unlocking bold thinking that turns science into reliable, compliant supply for people with devastating, often rare conditions. You will shape standards used across continents, deploy cutting-edge technologies from isolators to rapid methods and advanced analytics, and see your decisions translate directly into safer batches and uninterrupted care. We value kindness alongside ambition, encourage ownership beyond your lane, and back you with leaders who remove roadblocks so you can deliver what matters most: medicines patients can trust. Call to Action: Step in to define the global benchmark for sterility assurance, accelerate safer supply for patients and build a legacy of prevention—take the lead and apply today! Date Posted 10-Nov-2026 Closing Date 29-Nov-2026 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.