Sr. Manager, Quality Compliance, CAR T Manufacturing

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 we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.The Sr. Manager, Quality Compliance, CAR T is responsible for advancing a Compliance excellence mindset within Summit, NJs Cell Therapy Organization to meet or exceed Global Health Authority requirements and expectations across the product lifecycle. The Sr. Manager, Quality Compliance, CAR T plays a fundamental role in supporting and contributing to the execution of the quality compliance strategy for the Summit manufacturing site. The incumbent will work collaboratively with multiple departments across all functions and levels of the organization to provide strategic and tactical compliance support for the site. The incumbent will be responsible for leading site compliance activities involving health authorities, including evaluating significant quality events, leading fact-finding meetings for significant quality events, communicating status of significant quality events to the Senior Leadership team and authoring compliance reports to health agencies (Biological Product Deviation Reports (BPDRs) and Product Defect Notifications and Recalls). In addition, the incumbent will lead and coordinate critical compliance activities within Summit - including gap assessments, commitments, and responses to audit and inspection findings - and ensure any quality risks identified are proactively mitigated.Shift Available: Monday - Friday, Onsite Day Shift, 9 a.m. - 5 p.m.Responsibilities: Leads the Summit West (S12) Compliance team in the identification of Significant Events that may require a Notification to Management (NTM). Significant events are events that may impact quality of distributed product, disruption or significant delays in shipment to patients (e.g. Drug Shortage), market or field complaints deemed significant, and significant compliance events where Health Authority (HA) Notification is likely.Leads / Hosts Fact Finding meetings on behalf of S12 manufacturing for any Significant Events, including hosting the meeting, solving issues of significance, proposing a path forward, issuing minutes and ensuring all documentation is recorded in the Quality Management System.Issues Notifications to Management (NTM) for any Significant Events.Authors compliance reports to regulatory agencies, including, for example, Biological Product Deviation Reports to FDA (BPDRs), Product Defect Notifications to EMA or Drug Shortage Notifications.Communicates to site Senior Leadership Team regarding status of resolution, and interfaces with site external functions to drive resolution (e.g. Supplier Quality, Medical Affairs, Patient Safety, Regulatory Affairs, Global Quality Systems, etc.).Partners with Quality, Medical Affairs and Patient Safety to ensure completion of Integrated Health Hazard Assessments (IHHAs), when necessary.Ensures investigation of significant events are accurately communicated to the escalation team and apprises the escalation team of updates.Leads and coordinates critical compliance activities within S12 - including gap assessments, commitments, responses to audit and inspection findings, and ensures risks are properly mitigates.Participates in market recalls and mock recalls on behalf of S12.Collaborates with other relevant line functions to prepare and review regulatory submission documents, registration dossiers, and responses to health authorities, in scope of submission or periodic GMP review, upon request.Monitors compliance related processes (e.g. Product Quality Complaints, Notifications to Management, Mock Recall Assessments) to examine the overall health of the quality system in S12.Ensure site's inspection readiness and prepares the site for regulatory (health authority) inspections, provide front room and back room support and be responsible for generating response documentation.Performs other Quality Compliance projects as required by management.Knowledge & Skills:Strong written and oral communication health authority communication skills; English language fluency.Strong problem-solving skills.Prior experience in a compliance role (e.g. Health Authority inspection management, inspection readiness, recall, Quality System remediation, QMS implementation, etc.).Prior experience interacting with FDA or other regulatory agencies.Ability to collaborate with personnel at all levels within and outside of the company.Strong knowledge of multi-country cGMP regulations (e.g. U.S, EMA, Japan).Experience in biotech or CAR T is a plus.Proven experience working as a detail-oriented team player with effective planning, organization and execution skills.Innovative, proactive, and resourceful; committed to quality and continuous improvement.Ability to multitask and manage complex projects and timelines within a fast-paced environment.Ability to make independent and objective decisions, and to work with minimal supervision.Must be able to interact with and influence multidiscipline departments and CTO sites.Must possess an independent mindset and tenacity.Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.Excellent grammar and communication skills, both written and oral.Demonstrated proficiency in Microsoft Office applications.Basic Requirements: Bachelor's degree required. An equivalent combination of higher education and experience is acceptable.A minimum of 6 years of industry experience.At least 3 years of direct health authority interaction experience.A minimum of 3 years of experience in Quality deviation.Strong experience with continuous improvement within quality and regulations.Preferred Requirements: Advanced degree preferred.Experience in CAR T or Biologics is preferred.Professional certification in Regulatory Affairs or quality certifications is desired.Working Conditions: Work is performed in a typical office environment, with standard office equipment available and used.Work is generally performed seated but may require standing and walking for up to 10% of the time.Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.BMSCART, #LI-HybridIf 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 ProtocolBMS has a diverse 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 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.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: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.