Senior Manager, ITQM HA Inspection Support

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.

Responsibilities

• Lead the health authority inspection support end-to-end process for IT

• Facilitate inspection readiness, requests for information/documentation, and inspection response activities in support of internal and external health authority commitments

• Partner with IT subject matter experts to ensure that process and system overviews are developed and maintained in support of inspection interactions
• Provide continuous awareness to IT personnel on inspection related matters

• Lead the creation and dissemination of GxP inspection education and awareness content with evolving regulatory expectations

• Advise the overall IT risk management process of inspection related risks/mitigations as required

• Collaborate with ITQM, IT, business users and internal Global Quality compliance team to ensure that inspection activities are efficient, consistent, and compliant with external regulations and internal procedures

• Other specific responsibilities as assigned by the supervisor

Skills & Requirements:

• Extensive knowledge and experience of inspection management policies, processes, and protocols with ability to drive inspection preparedness and response actions.
• Thorough knowledge and understanding of the current regulatory expectations.
• Experience leading and driving multidisciplinary work groups or teams to meet objective across multiple inspection activities.
• Pharmaceutical background preferred. Understanding of the health authority regulations (e.g., 21 CFR Part 11 / Annex 11, Data Integrity) and statutory requirements.
• Must have proven ability to realign subject matter resources rapidly to meet changing inspection requirements and regulatory expectations.
• Bachelor’s degree in any related discipline.
• 5+ years of experience in IT / quality & compliance activities including audit and inspection support; 3+ years of experience in FDA regulated industry or equivalent; 2+ years of end-to-end process ownership and management experience.

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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