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Bristol Myers Squibb Manager, Quality Systems in Manati, Puerto Rico

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 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 .

Job Description Summary:

Supports quality computerized systems for QC/QA Department including Laboratories Information Management System, Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and standalone computers. Responsible for monitoring and improving quality computerized systems performance by identifying, developing and implementing initiatives to enhance system administration, data integrity compliance, CSV activities, and system's incidents resolution. Support of Company's manufacturing facility to ensure that cGMP's related IT Quality Systems are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS's business goals. Must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices as applicable.

Job Description Details:

  1. Support the Quality computerized systems for QC/QA Department including Laboratories Information Management System, Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and standalone computers.

  2. Act as the Quality Computerized Systems SME for the site, support internal and external regulatory audits, and assure all systems are in compliance with Federal, State and Corporate Regulations supporting BMS's business goals.

  3. Manages the administration of QC/QA computerized systems including user accounts configuration and maintenance, CSV documentation, system periodic review, audit trail (data and system) review, computerized systems incidents evaluations and investigations, standard operating procedures for administration tasks, addition/modification of printers, execution of backup/restore/achieve, and database optimization and analysis

  4. Manages the administration of Enterprise IT Support Systems (Document Management System, LIMS, Empower, etc.) at the site and assure all standard operating procedures, CSV support, investigations and troubleshooting activities are performed in compliance with site and corporate procedures, supporting BMS's business goals.

  5. Support data integrity assessments activities for new and existing quality computerized systems and assure all risks are mitigated prior to system release. Provide recommendation to remediate or mitigate findings, implement and validate modifications and assure the systems are maintained in compliance with regulatory requirements

  6. Support computerized systems data mappings development and/or revision to assure these are maintained in alignment with site operations and in compliance with regulatory requirements.

  7. Responsible for the development, execution, and/or review of CSV documentation for quality systems and the execution of change controls as needed by QC/QA Department.

  8. Performs project management functions for the execution, implementation, commissioning and validation/qualification of new and/or existing quality systems, including Enterprise solutions. Supervision and coordination of IT compliance contractors may be required. .

  9. Coordinates and executes the installation, maintenance, qualification, and validation of upgrades for existing quality systems and Enterprise solutions supporting QC/QA Departments.

  10. Fosters creative problem solving and provides technical guidance on computerized systems situations to Quality staff.

  11. Assures timely closure of incidents, investigations, audit observations, CAPAs and/or change control for quality computerized systems.

  12. Coordinate with suppliers of hardware/software and services for quality computerized systems problem resolution.

  13. Provides technical advice on the selection of equipment and system software for data acquisition and archival and other quality related systems.

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through scienceā„¢ , 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 Protocol

BMS 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1582913

Updated: 2024-07-01 04:14:08.667 UTC

Location: Manati-PR

Bristol 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.

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