Senior Manager, R&d Clinical Auditing

About Bristol Myers SquibbWe are a global biopharmaceutical company whose mission is to discover develop and deliver innovative medicines that help patients prevail over serious diseases Headquartered in New York City we are one of the world s largest pharmaceutical companies who have been fortunate to consistently rank on the Fortune 500 list of companies in the US About Bristol Myers Squibb HyderabadBMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions With our commitment to invest 100 million in Hyderabad over the next 3 years this important science technology and innovation centre will support a range of technology and global drug development activities that will help us usher in the next wave of innovation careers bms com working-with-usPosition Summary Works in the RDQ-Clinical Quality Assurance group CQA Conducts Good Clinical Practice GCP audits including investigator sites protocols process vendors and or internal systems and others as required to assess compliance with relevant regulations and applicable policies and proceduresActs as a subject matter expert SME in specific GCP related areas and may support manage Health Authority Inspections as assignedKey Responsibilities Perform GCP audits including investigator sites protocols process vendors and or internal systems and others as required to assess compliance with relevant regulations and applicable policies and procedures may function as a Lead Auditor for wide range of audit types Act as a strong technical resource for GCP topics May function as author SME of SOPs CQA and stakeholder-based and delivery of training to auditors in area of expertise Lead and or participate in CQA and or company processes and improvement initiatives as assigned Drive quality improvements with stakeholders Act as a SME in specific GCP related areas and may support manage Health Authority Inspections as assigned Perform peer audit report review as required Disclaimer The responsibilities listed above are a summary and other responsibilities can be added as assigned Travel Required Approximately 25 travel to perform audits and attend professional meetings and seminarsOvernight Absences Approximately five 5 overnight absences per monthQualifications ExperienceDegree Certification Licensure University Graduate in relevant discipline life sciences degree preferred Experience- Responsibility and minimum number of years Advanced working knowledge of principles and concepts of QA including those related to Quality Risk Management QRM Critical Thinking and Quality by Design QbD Advanced GCP auditing skills and inspection management skills Advanced knowledge of ICH-GCP Guidelines GxP Guidelines and regulations Advanced understanding of the drug development process and regulatory environment Advanced knowledge of other disciplines in stakeholders organizations to influence and support improvements in products processes and services At least six 6 years of work experience in clinical research and or a GCP related QA environment Four 4 years in GxP QA auditing ideally with clinical auditing experience Competencies- knowledge skills abilities other 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 Advanced verbal written communication skills including ability to clearly articulate information negotiate influence and interact effectively with auditees stakeholders and customers from different levels across R D including senior management and external organizations Fluent in English with proven professional working proficiency in English for reading writing and speaking Fluent in other languages as applicable to assigned region of responsibility Ability to manage competing priorities 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 Advanced skills in anticipating evaluating and solving multiple problems with varying degrees of complexity for CA and stakeholder functions Advanced skills in making tactical decisions and contributing to strategic decisions involving cross-functional teams situations Software that must be used independently and without assistance Demonstrates computer literacy Microsoft Suite SharePoint Veeva Vault RAVE other systems as assigned applicableIf you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role which the Company deems critical to collaboration innovation productivity employee well-being and engagement and it enhances the Company culture BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations