Manager, PV Audit

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. 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: Key ResponsibilitiesLead and coordinate internal and external pharmacovigilance audits of the BMS PV System and its Quality System (including Critical processes, Affiliates, Licensing Partners, Service Providers/Vendors, Distributors, and NI PASS) to ensure compliance with regulatory requirements, company procedures and contractual arrangements.Document audit findings and prepare detailed audit reports in line with procedural timelines.Support and advise on the development of appropriate corrective and preventive actions.Proactively manage findings, responses and CAPA arising from audits in the BMS Quality Management system.Review the effectiveness of actions to address audit findings.Maintain expertise in country-specific and global PV regulations and guidelines.Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.Support inspection activities (i.e. mock interviews, document review, back-room support, as required).Additional Quality activities as assigned. Qualifications & ExperienceDegree/ Certification/ Licensure:Bachelor's degree in pharmacy, Medicine or Life Sciences or equivalent experience.Experience- Responsibility and minimum number of years:A minimum of 5 years' experience in Pharmacovigilance/Regulatory Affairs/Clinical Safety/Medical Affairs.Quality Assurance/Compliance and PV Auditing experience or equivalent combination of education, training and experience in Pharmacovigilance.Demonstrated expertise and specific technical knowledge of clinical safety and pharmacovigilance, regulatory affairs and/or medical affairs activities of at least 5 years in the pharmaceutical industry or equivalent.Demonstrated knowledge of global PV legislation and guidance, medical affairs and regulatory processes and principles of Quality Assurance.Demonstrated applied knowledge of pre-and post-marketing regulatory requirements.Analytical, organizational and planning skills.Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data.Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.Other:GCP auditing skills, ICH-GCP Guidelines and inspection management skills are added advantages.Preferred good knowledge of the drug development process and Pharmacovigilance System requirements / GxP Guidelines and regulationsIf 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 a supportive culture, promoting global participation 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 ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.