Senior Manager, IT/CSV Auditor
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.
Global Quality GxP Information Technology Quality Assurance (GQ GxP-ITQA) ensures all GxP computerized systems across the end-to-end product lifecycle meet BMS standards and global regulatory authority requirements and expectations.
The position is in the Global Quality GxP IT Quality Assurance (GQ GxP-ITQA) department within the Audit Operations tower, and is responsible for auditing all processes related to GxP computerized system development, operational use, maintenance, and retirement, to assess compliance with relevant electronic record and electronic signature (ERES) regulations and guidance, as well as applicable GxP regulations and BMS quality standards.
Key Responsibilities and Major Duties
- Plan, organize, execute, and document audits of Health Authority regulated computerized systems and related operations and IT controls. The audits are intended to assess compliance with appropriate global health authority regulations, guidance, and company policies and procedures and to further assure the quality and integrity of the data managed by these computerized systems. Includes internal and external (vendor and/or contract service provider) audits.
- Utilize a risk-based approach in the development of audit scope with a focus on IT computing controls impacting patient safety, product quality and data integrity.
- Conduct comprehensive audits in a professional manner and following a structured protocol aligned with the audit scope. This includes, but may not be limited to, preparing an audit agenda, running opening, and closing meetings, conducting interviews, conducting sample-based evidence testing, and reviewing key artifacts in support of identifying areas of risk, non-compliance, or non-conformance.
- Prepare clear, concise, accurate and evidence-based audit reports to effectively communicate audit findings and recommended corrective action to management. Discern significant audit issues and identify appropriate recommendations. Review and assess corrective and preventive action plans according to specified timelines to assure resolution of audit findings and prevent re-occurrence. Maintain detailed documentation supporting the audit.
- Maintain an in-depth knowledge of governmental regulations which impact the development and use of computer systems as well as relevant BMS policies and procedures.
- Analyze documentation, process information, technical configurations, information architecture, data process flows, or other client provided information and document the results of conversations and analysis.
- Research new technologies, understand existing processes, and reference recognized regulations, standards, and frameworks.
- Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
- Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.
- Identify opportunities for continuous improvement.
- University Graduate, preferably with a BS in Life Sciences or Computer Science/Information Systems
- Certified Information Systems Auditor (CISA) certification or equivalent preferred
- Preferred to have at least 6-10+ years of relevant auditing experience - performing systems audits for FDA Part 11 and EU Annex 11 compliance.
- Must be able to lead audits independently or with a team
- Relevant GxP experience (GCP, GLP, GMP, GVP, GDP) required.
- Experience in the Biotech/Pharmaceutical Industry or similar regulated industry required.
- Excellent analytical, interpersonal and communication skills, including written and verbal communication.
- Previous experience as a lead auditor preferred, for a life sciences company regulated by the FDA.
- In-depth understanding of industry accepted software development and validation life cycle programs and related IT computing controls.
- In-depth understanding of data integrity principles and controls including but not limited to audit trail review, pattern recognition and detection, user access and security, etc.
- Previous experience in risk-based approach to auditing and computerized system validation a plus. Understanding of quality risk-management concepts (ICH Q9) preferred.
- Ability to write audit observations clearly and concisely is a must. Writing samples are required.
- Strong critical thinking to analyze complex situations and discern critical issues.
- Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
- Strong sense of ethics, diplomacy, and discretion.
- Commitment to Quality.
- Ability to work effectively with a diverse, multicultural workforce.
- Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Ability to effectively work in multi-disciplined team environment to achieve goals.
- Highly collaborative and must embrace and support teamwork. The ability to communicate and operate effectively with all employee levels is required.
- Experience with relevant electronic systems such as audit management systems, quality management systems, document management systems, and training/learning management systems preferred.
Travel Required (nature and frequency)
- About 25-50% travel to conduct audits (both domestic and international), meet with stakeholders, and attend professional meetings and seminars.
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.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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