Senior quality operations manager - united kingdom, addlestone, surrey

senior quality operations manager about astellas: at astellas we are making treatments that matter to people. we are tackling the toughest health challenges putting the patient at the heart of every move we make. our global vision for patient centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. at astellas, patient centricity isn't a buzzword - it's a guiding principle for action. we believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. we have developed ground-breaking, innovative medicines in immunology, oncology and urology. our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. we take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives. from lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners. about this job: this role is responsible for the development and maintenance of the astellas quality management system (qms), with a focus on the capa management system. this involves implementing, executing, and administrating astellas qms programs, policies, processes, procedures, and controls in compliance with evolving global regulatory requirements of the pharmaceutical and medical device industries (as applicable).this also involves supporting astellas regulatory affairs, pharmacovigilance, development, medical affairs, and other functions that operate under the astellas qms. contributes to the development, implementation, and successful execution of the astellas quality assurance mission, objectives and strategic plan. essential job responsibilities: ensures collaboration and builds partnerships with stakeholders to execute quality strategies for driving continuous improvement through the quality system. participation in the development and execution of the quality assurance internal system audit schedule, conducting audits, monitoring adherence to company policies and applicable regulatory requirements, and reporting findings to audited departments for issue resolution. active participation in the management of the corrective and preventive action program, tracking completion of required corrective and preventive actions as a result of reported quality issues (e.g., nonconformities, internal audits, and external regulatory inspection commitments) develop and utilize tools to track, trend and report compliance metrics to ensure astellas systems and processes are suitable, effective, and comply with regulatory authority requirements. compile and analyze compliance metrics for presentation as part of the management review program. monitoring current industry compliance trends, emerging regulations and regulatory intelligence to ensure maintenance of the quality management system. author, revise and perform maintenance of department controlled documents (e.g., sops, wpds, etc.) as necessary. develop and deliver training on compliance and education for quality management system processes. provide guidance on regulatory requirements and compliance to functional areas, and represent the company with regulatory authorities by facilitating/supporting regulatory inspections and third party audits, as required, in collaboration with appropriate functional areas, to ensure successful inspectional outcomes. essential knowledge & experience: excellent quality assurance experience in the pharmaceutical industry capa management system leadership good project management experience in multicultural global setting proficiency in microsoft suite strong interpersonal skills and experience in cross cultural environment ability to negotiate and build consensus for plans and priorities, able to develop effective relationships with colleagues and stakeholders excellent oral and written communications well as presentation skills. demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to the complex problems and build consensus across the global organization ability to generate insights and leverage learnings individuals, teams and functional level. strong planning and organizational skills and experience managing multiple priorities simultaneously preferred knowledge & experience: advancd degree preferred education and qualifications: bachelors degree in related area

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