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Senior Manager, Clinical Auditing

New Brunswick, NJ Full Time Posted by: Bristol-Myers Squibb Posted: Wednesday, 22 May 2024
 
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job.

But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.At Bristol Myers Squibb, the Research and Development Quality - Clinical Auditing organization (RDQ-CA) is responsible for the auditing of clinical trials and associated systems. RDQ-CA audits all processes related to clinical research, 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.

RDQ-CA also offers support as Subject Matter Experts for GCP related auditing topics as required.The Senior Manager of Clinical Auditing will work in the RDQ-CA group and will conduct 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 procedures. The incumbent will also act as a Subject Matter Expert (SME) in specific GCP related areas and may support/manage Health Authority Inspections as assigned.

Key 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 topicsMay function as author/SME of SOPs (Clinical Auditing team and stakeholder-based) and delivery of training to auditors in area of expertiseLead and/or participate in clinical auditing and/or company processes and improvement initiatives as assignedDrives quality improvements with stakeholdersAct as a SME in specific GCP related areas and may support/manage Health Authority Inspections as assignedPerform peer audit report review as requiredKey Requirements:University Graduate in relevant discipline (life sciences degree preferred)At least 6 years of work experience in clinical research and/or a GCP related QA environmentFour (4) years in GxP QA auditing preferred, ideally with clinical auditing experienceAdvanced 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 skillsAdvanced knowledge of ICH-GCP Guidelines/GxP Guidelines and regulationsAdvanced understanding of the drug development process and regulatory environmentAdvanced knowledge of other disciplines in stakeholder's organizations to influence and support improvements in products, processes, and servicesAdvanced verbal/written communication skills and ability to communicate with various stakeholdersFosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issuesEscalates issues to appropriate people within department/organizationDemonstrates commitment to delivering high-quality work productAble to function independently within an environment that relies heavily on technology for information and communicationAdvanced skills in anticipating, evaluating, and solving multiple problems with varying degrees of complexity for Clinical Auditing and stakeholder functionsAbility to travel up to 25%you come across a role that intrigues you but doesn't 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 CareersWith 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 ProtocolPhysical 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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

New Brunswick, NJ, USA
Healthcare
Bristol-Myers Squibb
AJF/707484064
22/05/2024 01:41

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