Sr. Manager, Quality Assurance for Quality Control at Bristol Myers Squibb

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Feb, 26

Salary

150800.0

Posted On

16 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Control, Analytical Development, Method Development, Validation, Microbiological Assay Methodologies, GMP Regulations, Regulatory Compliance, Leadership, Communication, Attention to Detail, Decision-making, Risk Management, Laboratory Operations, Continuous Improvement, Data Review

Industry

Pharmaceutical Manufacturing

Description

Working with Us Challenging. 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: 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. Summary The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Manager provides Quality support and oversight for QC laboratory operations such as sample management, testing, and data review, method development, validation, and transfer, equipment validation, and associated projects. The Senior Manager supports thorough review and approval of QC investigations, change control records, Standard Operating Procedures, Method validation and transfer documents, and technical protocols, and assists in preparing for regulatory audits. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. ·Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects. ·Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities. ·Assesses QC driven change controls and supports completion of any associated change actions. ·Participates in ongoing laboratory operations/continuous improvement and risk management projects. ·Participates in risk assessments related to QC laboratory operations. ·Identifies and reports discrepancies from required work practices or procedures to management. ·Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate. ·Participates as requested in the response team for audits and inspections by health authorities. ·Conducts regular walkthroughs of QC laboratories. ·Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents. ·Provides oversight to identify and implement changes that lead to realization of long-term department and company goals. Education and Experience ·Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required. ·Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required. Quality Assurance experience would be considered beneficial. An equivalent combination of education and experience may substitute. Skills and Qualifications ·Knowledge of analytical method lifecycle including development, validation, and transfer ·Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP) ·Knowledge of Microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin. ·Knowledge of common QC and environmental monitoring procedures and techniques. ·Equivalent combination of education and experience acceptable. ·Strong background and demonstrated effectiveness in quality assurance operation and compliance of Clinical and commercial Quality laboratory operations. ·Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired. ·Knowledge of US, EU and rest-of-world cGMP regulations and guidance. ·Knowledge and proven experience in FDA, EMA, or other regulatory authority. ·Demonstrated leadership, interpersonal, communication, and motivation skills. ·Excellent writing and oral communication skills are required. ·Previous work responsibility, which required a high degree of attention to detail. ·Well-practiced in exercising sound judgment in decision-making. ·Demonstrated prioritization and organization skills. Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. The starting compensation for this job is a range from $124,449 - $150,800, 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 https://careers.bms.com/life-at-bms/. 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. #RayzeBio, GPS_2025, #LI-Onsite Work Environment The noise level in the work environment is usually moderate. If 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. Compensation Overview: Indianapolis - RayzeBio - IN: $141,515 - $171,483 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/. 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. Uniquely Interesting Work, Life-changing Careers With 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 Protocol BMS 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 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. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control laboratory operations in accordance with policies and global cGMP. This includes providing support for sample management, testing, data review, method development, and regulatory audits.