Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives. Responsibilities: This role will report to the Director of Regional Clinical Compliance who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). Responsibilities will include: In partnership with the Regional Clinical Operations and Global Quality, support the regional study teams and sites to assure inspection and audit readiness at all times. Lead the implementation of the Quality Audit Plans with on-site support during Health Authority site Inspections and/or HA sponsor inspections, and coordinate these inspections as necessary. In partnership with the Regional Clinical Operations teams, provide Clinical Research Associates oversight including co-monitoring visits. Work closely with the Clinical Quality and Risk Management team and help identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance. Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness. Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed. As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical. Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset. Qualifications: A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required. Fluency in a second language relevant to the geographical scope is a plus. Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions. Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities). Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner. Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills. The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way. By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact ...@bms.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, click here. Bristol-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. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information. Associated topics: aseptic, drug development, histology, immunoassay, industrial hygienist, nephrology, physiologist, therapeutic, therapy, transfection
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.