About the job Specialist, GCP Quality
Job Title: Specialist, GCP Quality
Job Location: New York, NY, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Associate Working with UsChallenging. Meaningful. Life-changing. Those arent 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. Youll 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 .RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.RayzeBio is seeking a Specialist of GCP Quality. This role will be responsible for assisting in the coordination and implementation of Good Clinical Practice (GCP) related quality assurance activities for RayzeBios Clinical Development team. These responsibilities include supporting the execution and maintenance of the audit program focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and RayzeBios policies and procedures. The Specialist of GCP Quality manages the tracking of audit findings, Corrective and Preventive Actions (CAPAs) and Non-conformances, as needed. Additional responsibilities include supporting RayzeBio inspection readiness plan. This position will report to the Sr. Manager, GCP Quality and oversee GCP quality functions within RayzeBio.Key Responsibilities
- Support and maintain GCP quality management systems, policies, and SOPs
- Monitor, track, and trend GCP non-conformances, deviations, CAPAs
- Support GCP audit activities, internal and external, including conducting clinical vendor qualifications and audits, conduct investigator site audits
- Support and maintain the internal audit program, audit schedule, and approved vendor list. May be involved in the conduct of both internal and external audits.
- Work closely with clinical study management teams to provide clinical compliance information, help identify issues, support continuous improvement and help identify and mitigate risks.
- May serve as GCP QA Subject Matter Expert (SME) for assigned clinical stage programs, ensuring balance between operational timelines and compliance requirements.
- Assist in writing and reviewing operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS)
- Assist in developing reports quality/KPI metrics to support GCP activities and management review
- Responsible for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.
- Assist with inspection readiness activities which include operating per the inspection readiness plan, risk mitigation and inspection readiness training.
- 10% of travel may be required
Education Experience
- Bachelors degree or higher
- Minimum 5 years in GxP (GMP, GLP, GCP) pharmaceutical environment in progressively responsible Quality roles or 3 years with advanced degree. Highly desirable to have a minimum of 3 years of Quality Systems experience.
- Understanding of US and European regulations including application in the day-to-day environment
- Previous experience with regulatory agency inspections
- Ability to successfully solve challenging issues, critical thinking, and detail oriented
- Strong interpersonal, verbal, and written communication skills
- Demonstrable record of strong teamwork in a cross-functional industry environment.
- Previous experience in a start-up company preferred
Skills And Qualifications
- Excellent written and verbal communication skills.
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous with detail and precision
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
- Strong communication and interpersonal skills
- Should be assertive, proactive, professional, and confident
- Excellent professional ethics and integrity
- Flexibility to adapt in a cross-functional and dynamic environment
T he starting compensation for this job is a range from $ 68,759-93,027 , 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 experienceIf you come across a role that intrigues you but doesnt 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 roleSite-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 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. Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.Please use the below Lifelancer link to Apply and view similar roles.