Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied. Senior Manager Research and Development Quality - Clinical Trials Quality Assurance (RDQ-CTQA) is responsible for the quality governance and auditing of clinical trials and associated systems. RDQ-CTQA defines the Clinical Quality Management Systems (QMS) enabling strategies and technologies and coordinates Quality Risk management at the compound and process levels to inform the audit focus and drive implementation of Quality Risk Management. RDQ-CTQA audits all processes related to clinical research, including investigator site, country, process, vendor and partner audits, to assess compliance with relevant regulations and applicable policies and procedures. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements. RDQ-CTQA also offers support as Subject Matter Expert during Due Diligence and if areas of serious non-compliance are identified. Purpose of the job The Senior Manager will work in the RDQ-CTQA group. This group conducts Good Clinical Practice (GCP) audits off clinical investigator sites, vendors, internal systems/processes; lead/collaborate on due diligences and pre-qualification audits. The manager will also act as an expert in specific GCP related areas and may support Health Authority Inspections as assigned. Key Responsibilities and Major Duties Perform GCP audits of clinical investigator sites, vendors and/or internal systems including pre-qualification audits to assess regulatory compliance (may function as a lead auditor for wide range of audit types) Act as an expert resource for a certain GCP topic within RDQ-CTQA and may function as SME (providing advice and counsel) for the concerned area for the development of SOPs (QA and stakeholder-based) and delivery of training to auditors in the area of expertise Participates into GPS and/or BMS company processes and improvement initiatives Support other areas within RDQ in the creation and maintenance of project/study audit plans while preparing and post audit conduct of wide range of audits (e.g. pointing newly identified risks to be explored in further audits) May assist/support local HA inspections Represent RDQ-CTQA position during internal meetings The responsibilities listed above are a summary and other responsibilities can be added, as assigned Requirements BA/BS degree (University Graduate), Life Sciences degree preferred Demonstrated working knowledge of principles and concepts of QA including those related to QRM and Critical Thinking Solid GCP wide range of auditing and/or inspection management skills Solid working knowledge of ICH-GCP Guidelines Solid understanding of applicable worldwide clinical research requirement/regulations Solid understanding of the drug development process and regulatory environment Comprehensive business and technical knowledge/experience to improve products, processes and services. Experience in clinical QA auditing and / or significant work experience in clinical research and/or GCP related QA environment Competencies - Knowledge, skills and abilities Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for GCP audit findings or issues consistent with company policy, regulatory references and business strategy. Strong verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members Strong negotiation and influencing skills collaborate effectively with cross-functional team members Fluent in English and other languages as applicable to assigned region of responsibility Maintains the confidentiality and security of information, data, documents and records Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues Understands interdependencies Escalate issues to appropriate people within department/organization Demonstrates commitment to delivering high-quality work product Able to function independently within an environment that relies heavily on technology for information and communication Sense of diplomacy and discretion Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment Approximately 25% travel to perform audits and attend professional meetings and seminars Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor. Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.