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Job Details


Bristol-Meyers Squibb, Co.

Sr Director, IT Validation Services (R1557934-en-us)

Pharmaceuticals

All

Yearly

No

Princeton, New Jersey, United States

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.

This role will lead teams whose focus is to ensure that IT delivery teams can plan and execute computer system validation in a consistent manner aligned with BMS policy and Health Authority regulatory expectations. This function is aligned with BMS’ “three lines of defence model” and is responsible for activities that fall under the first line of defence. The leader will oversee several teams whose responsibility is to deliver and oversee Computer System Validation (CSV) for portfolio of digital capabilities and GxP applications across multiple business functions including; GPS, R&D and Commercialization. The teams focus is to execute CSV for IT projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures. Responsible for GxP Periodic Review processes aligned with regulatory expectations. Collaborate with IT Business Partners, Digital Capability management and Delivery leads, business users and Global Quality function to execute effective and efficient quality strategies for compliance and validations strategies for IT capabilities. The lead of this function will actively engage in the IT portfolio process to ensure appropriate engagement and resource allocation to the execution of projects on GxP systems.

Responsibilities include:

Manage a team whose responsibility is to plan and execute validation activities across all IT portfolio.Coach team members and collaborate with peers in other quality assurance and compliance organizations within BMS in developing and implementing validation plans to assure compliance to regulatory requirements and BMS policies. Responsible for overseeing CSV activities executed for portfolio of IT capabilities across all in scope functional areas to ensure 'fit for use' before release to production environment. Responsible for GxP Periodic Review process. Liaison with Global Quality (GQ) to support Health Authority regulatory inspections.Ensure effective and efficient quality strategies for compliance and validations strategies are defined across all in scope areas and related technology solution so that IT systems are in alignment with internal expectations and relevant governmental regulations and guidelines related to Data Integrity. Lead program to effectively implement BMS’ revised global CSV PD and adopt CSA methodology to develop validation strategy for project execution.Comprehensive knowledge of GxP and IT General Controls and experience evaluating and implementing controls under different regulations and legislation requirements (such as FDA and other Health Authority) related to validated systems. Understanding of the applicable regulations, laws, and industry frameworks, including those impacting Manufacturing Plants and Laboratory Systems. Apply understanding of key business drivers to accomplish team objectives and influence work across matrixed teams and ensures adherence to software development practices, compliance, and key IT controls.Anticipate business and industry challenges and recommends best practices-based solutions to improve products, processes, systems Identify and implement continuous improvement through enhanced technology solutions that improve digitization, compliance and productivity.

Requirements:

15 years experience in pharmaceutical industryStrong management and leadership experienceDemonstrated knowledge in validation practices on enterprise and local systems across GMP, GCP, PV and/or GLP.Expertise in CSV, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines.Knowledgeable in Software Development Lifecycle (SDLC) and demonstrated ability to execute and organize teams effectively across portfolio of IT capabilities and programs. Ability to establish strong relationships and influence with senior leadersInsight to industry practicesStrong matrix leadership skills

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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

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