Senior Manager, R&D Clinical Auditing

About Bristol Myers Squibb:

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position: Sr. Manager, R&D Clinical Auditing

Manager: Associated Director, Auditing

Location: Hyderabad, India

Working with Us:

Challenging. 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

Position 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 procedures

Acts 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 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 seminars

Overnight Absences: Approximately five (5) overnight absences per month

Qualifications & Experience

Degree/ 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 stakeholder's 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/applicable

If 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 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 [Confidential Information]. 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.