Manager, IT Compliance

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The incumbent will be accountable for the strategies executions for IT Computerized Systems, Computer System Validation and Data Integrity Compliance for Computerized Systems, to assure site adherence to regulatory requirements, BMS Corporate CSV and Data Integrity Directives, and site procedures and methodologies.
The incumbent will perform computerized systems validation for the site systems at the Sterile, Non-Sterile, Utilities, Facilities and QC/QA functional areas at Bristol-Myers Squibb Manati manufacturing facility according to all Federal, International, State and Corporate Regulations. Responsible for the design, development and execution of software & computer validation protocols and computer validation plans for computerized systems supporting the site areas. Assure the systems are compliant with all CSV and data integrity requirements for computerized systems before releasing the system for its intended use. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function applicable.

• The incumbent must assures IT Compliance commitments (computerized system validation (CSV), data integrity for computerized systems, quality compliance) are planned, closely monitored and completed as expected, following all applicable regulations.
• Keep abreast of regulatory developments applicable to IT Systems, within or outside of the company, as well as evolving the department’s best practices in compliance control.
• Serve as the Site IT Subject Matter Expert for IT Compliance issues, including but not limited to Data Integrity for Computerized Systems and Equipment for Control Systems, 21 Code of Federal Regulations (CFR) Part 11, and computer system validation (CSV) in support of laboratories, manufacturing, and packaging operations.
• Ensures the development, implementation, execution and sustainability of an efficient Software/Computer System Validation Program for Business, Manufacturing and Quality Systems, aligned with regulatory requirements, Corporate Directives, and site policies.
• Ensures Periodic Reviews for computerized systems are completed as per plan and aligned with regulatory requirements, and site and corporate procedures.
• Develops and maintains an effective process to ensure system documentation such as: requirements, specification, drawings, data mappings, qualification protocols and equipment manuals of computerized systems are properly maintained.
• Identifies computerized systems validation needs through in-house assessments.
• Ensures the execution and sustainability of an efficient Data Integrity Program for computerized systems supporting Business, Manufacturing, Utilities/Facilities, Packaging and Inspection Areas, aligned with regulatory requirements, Corporate Directives, and site policies.
• Performs data integrity assessments activities for new and existing site computerized systems and assure all risks are mitigated prior to system release.
• Leads the detection and evaluation of Data Integrity systems deficiencies for the implementation of corrective actions, which will assure correct operation and compliance to regulated agencies requirements.
• Ensures execution plans for computerized system validation, SDLC for eBRs and Data Integrity compliance are performed as per regulatory requirements, and site and corporate commitments Provide recommendation to remediate or mitigate data integrity findings in computerized systems, implement and validate modifications and assure the systems are maintained in compliance with regulatory requirements
• Develops computerized systems data mappings to assure these are maintained in alignment with site operations and in compliance with regulatory requirements.
• Fosters creative problem solving and provides technical guidance on computerized systems situations, including data integrity.
• Assures timely closure of incidents, investigations, audit observations, CAPAs and/or change control for quality computerized systems.
• Communicates to management potential Data Integrity systems situations, which can affect quality or compliance to ensure that appropriate management action is taken to correct these problems.
• Support regulatory agencies inspections on IT Compliance and Data Integrity requirements.
• Supports the implementation of computer systems and provides guidance to assure compliance with Data Integrity requirements and all regulatory requirements, company policies and procedures.

Decision Making:

• Act as the site IT Compliance SME for CSV and Data Integrity Requirements. Responsible for the implementation and support of IT initiatives, and the management and implementation of Bristol-Myers Squibb Company policies on site computerized systems.
• The incumbent is encouraged to take action to resolve issues identified to assure the site computerized systems are always available and in compliance to support manufacturing related activities.
• Decides on acceptability of computerized system validation activities for new equipment and their compliance with data integrity and all applicable regulatory requirements. The decisions taken are often determinant in preventing loss of site systems’ data. The impact of these decisions could affect the regulatory posture of BMS.

Others:

• The incumbent is expected to work independently to accomplish agreed goals and objectives. Final actions are limited by existing operational procedures, policies and internal controls.

Knowledge and Skills:

• Bachelor Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• Experience computerized system validations (CSV) methodologies, 21 CFR Part 11, and Data Integrity regulations for Computerized Systems.
• Minimum of Four (4) years of computerized system validation and data integrity within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile and non-sterile operations.
• Proven skills in project management.
• Ability to impact and influence people/areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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