Associate Director, Clinical Auditing

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, Research and Development Quality - Clinical Auditing (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.Position SummaryThe Associate Director of Clinical Auditing is responsible for conducting 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. This position will report to the Director of Clinical Auditing.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)

Acts as an expert for GCP and/or Clinical Operations topics

Function as SME to internal customers, as well as to regional and functional lines, RDQ, and stakeholders and provide direction or strategy relative to technical expertise

Called upon to resolve GxP issues and provide direction or strategy relative to technical expertise

Assesses and supports the implementation of emerging regulations based on areas of technical expertise

May function as author/SME of SOPs (CA and stakeholder-based) and delivery of training to auditors in area of expertise

Lead CA and/or company processes and improvement initiatives as assigned

Drives 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 and/or audit report review as a management representative, as assigned

May influence the external environment through interactions with regulators, trade associations, or professional societies (i.e., PEARL teams, etc.)

Key Requirements:

A minimum of 8 years of work experience in clinical research and/or a GCP related QA environment

Six (6) years in GxP QA auditing preferred, ideally with clinical auditing experience

University Graduate in relevant discipline (life sciences degree preferred)

Expert working knowledge of principles and concepts of QA, including those related to Quality Risk Management (QRM), Critical Thinking and Quality by Design (QbD)

Expert GCP auditing skills and inspection management skills

Expert knowledge of ICH-GCP Guidelines/ GxP Guidelines and regulations

Expert understanding of the drug development process and regulatory environment

Expert knowledge of other disciplines in stakeholder organizations influence and support improvements in products, processes, and services

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

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

The starting compensation for this job is a range from $141,000 - $178,000, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.Final, individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.#LI-RemoteIf 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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.Company: Bristol Myers SquibbReq Number: R1577580Updated: 2024-01-17 16:03:58.150 UTCLocation: Devens,MassachusettsBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.