Sample Management Manger, Clinical QC

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 .Title: Sample Management Manger, Clinical QCLocation: Warren, NJAt 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 Sample Management (SM) Manger, Clinical QC reports to the Associate Director of Clinical QC and will manage the daily operations of the QC Sample Management team and is r esponsible for QC SM scheduling, routine management of in-process, final product and stability samples as well as QC data throughout the sample lifecycle from receipt to disposition. The QC SM manager also oversees the periodic sample and data inventory maintenance activities, among other activities . The SM Manager will also be responsible for hiring, mentoring, and developing the QC SM team to support business operations and employee career development and ensuring general business continuity regarding product manufacturing as it relates to Sample management activities.Key Responsibilities:

Leading SM team in Sample Management GMP processes for in-process and final drug products and ensure effective, timely and efficient operations and compliance with cGMP requirements.

Lead by example to foster a culture of teamwork and operational excellence and embed BMS values within operational activities.

Support, maintain and report KPIs for QC SM operations performance. Maintain high team performance and drive continuous improvement using operational excellence tools.

Use and support team with laboratory LIMS, ELN, and ERP systems (e.g., SAP).

Able to manage and oversee SM team with minimal management oversight.

Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

Author, interpret and review general, technical, and complex technical and quality documents.

Represent the department in regulatory inspections.

Provide Guidance and Leadership

Perform on-the-job training (OJT) for the SM team .

Lead and support the SM team with development, implementation, and deployment of training.

Lead and support SM team in troubleshooting of patient lot harvest for SM methods, SOPs, etc.

Ensure the SM maintenance compliance with documentation, practices, and all required BMS activities.

Lead and develops best practices.

Qualifications & Experience:

Bachelor's Degree required, preferable in Science.

3+ y e ars o f relevant work experience, preferable in a regulated environment.

An equivalent combination of education and experience may substitut e.

Advanced experiences in Sample Management and GMP processes for in-process and final drug products.

Experience with laboratory LIMS, ELN, and ERP systems (e.g., SAP) preferred.

Able to manage and oversee SM team with minimal management oversight.

Advanced ability to accurately and completely understand, follow, interpret , apply Global Regulatory and cGMP requirements .

Advanced verbal and written communication skills as well as technical writing skill s. Advanced organizational and time management skills.

Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.

Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.

Requires strategic thinking and ability to work independently.

Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.

Ability to interpret and author general, technical, and complex technical and quality documents.

Advanced knowledge and implementation of data integrity principles.

Ability to represent the department in regulatory inspections.

Ability to work collaboratively in a high-paced team environment, meet deadlines and prioritize work for multiple teams/programs.

Proficiency in MS Office applications.

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 30% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.#LI-OnsiteBMSCARTVETERANIf 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 [email protected] . 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company: Bristol-Myers SquibbReq Number: R1583289Updated: 2024-07-07 02:02:49.834 UTCLocation: Warren-NJBristol 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.