Position Summary:The Senior QC Manager will be responsible for analytical testing of commercial products at Alexion QC, centralized tasks such as certificate of analysis generation for External QC product and cert approval. The position will establish and maintain the governance process and quality metrics for these areas. They will be accountable for release testing for all Alexion RDU commercial products, with support of In-Country Testing activity, including forecasts, budget, contracts, metrics, testing, investigations, deviations and Quality Agreements. The position will also have a Compliance focus, including responsibility for audit readiness, risk register and Quality Management Review at External QC. The position will work closely with Global QC teams to ensure alignment and seamless execution of shared areas of responsibility. The role can also deputise for the Associate Director External QC.Principle Responsibilities:Leading Compliance process within External QC. Accountable to establish and maintain the Global QC Risk Register process. Leading Quality Management Review readiness for External QC, and partnering with internal Alexion QC Labs (ADMF, AAMF, AGAMF) to achieve QMR commitments.Leading the sourcing strategy for External QC, including lab selection for commercial testing, secondary transfers, business continuity management, external network review.Leading the contract laboratory performance management process. Accountable for the design and delivery of performance management and governance across the contract laboratory network.Leading and owning the Risk Register process and governance process for External QC. This includes establishing and maintaining a risk management process to maintain oversight for on-going performance and selection of Contract Laboratory Organizations.Supporting the preparation for Notification to Management meetings, including content preparation and presentation.Leading significant investigations for External QC, including root cause analysis, risk assessment, analytical technical support, compliance support.Leading and co-ordinating External QC audit readiness, including preparation of audit content, data packs, storyboards, presenting to auditors, preparing team members to present to auditors and supporting audits. This includes all audits such as internal audits and Health Authority audits.Leading and owning the process for the Quality & Compliance metrics and trends, and co-ordinating the reporting of these metrics for External QC. This includes weekly, monthly and quartlerly metrics, Quality Management Review, Governance Calls with Contract Laboratory Organizations.Accountable for other Compliance processes for External QC, including on-time Periodic Review, Post Marketing Commitment tracking and reporting to Health Authorities, training process and curricula and change controls.Qualifications:B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.Minimum 10 years of laboratory experience in a GMP laboratoryProven ability to work in a matrixed organization.In depth understanding of current regulatory requirements for QC, including QC testing, data integrity, supplier management, method transfer.Knowledge of business and management principles involved in resource allocation and financial management.Experience of Trackwise, Empower and documentation systems would be an advantage.EducationB.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.Competencies:Proven ability to work in a matrixed organizationBusiness process mapping experience preferred.Has previously demonstrated success in managing a cross functional team.Project management skills.Excellent written and verbal skills and strong interpersonal skills.High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPointStrong organizational, conflict management and decision-making skills are required.Experience of involvement in technical issue resolution, in a multidisciplinary environment.Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.Ability to travel up to 20%Date Posted14-Feb-2025Closing Date28-Feb-2025Our 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.