Bristol Myers Squibb
Senior Manager, Audit Intelligence Coordinator
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Manager, Audit Intelligence Coordinator
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Senior Manager, Audit Intelligence Coordinator
role at
Bristol Myers Squibb .
Position summary
Reporting to the Senior Director, Operations & Performance, the Senior Manager, Audit Intelligence Coordinator is responsible for planning audits in support of the BMS Competitive Compliance Audit Program. This includes coordinating audits for internal sites, global suppliers, and entities such as CMOs, APIs, raw materials, and external labs. This role involves planning, organizing, and scheduling audit assignments in accordance with the global audit plan. It also supports clinical and commercial business developments through due diligence audits and communicates any changes in the global audit plan to stakeholders and audit outsourcing partners. Utilizing data-driven insights, this role aims to enhance audit planning and execution, ensure the audit program's health and performance, and integrate with internal processes such as QRM and Quality Council.
Key Responsibilities
Develop and implement an annual audit plan using risk-based principles and data-driven decision-making.
Plan, organize, and schedule audit assignments in collaboration with Audit Operations, in accordance with the defined audit program and audit plan.
Work with key stakeholders to maintain and update the annual audit plan for both planned and unplanned changes including routine, due diligence audits, pre-approval inspection readiness, directed or for-cause audits, acquisitions, regulatory/agent distributors, labeling and inspection readiness.
Enhance efficiency and simplify the management of the audit planning process by leveraging digital solutions such as automation and AI to advance strategic initiatives and focus on high-impact areas.
Communicate with stakeholders, Audit Operations, lead auditors, and audit outsourcing partners regarding global audit plan changes in a timely manner.
Periodically review and update the audit plan using current compliance, quality, data intelligence, and risk-based principles.
Ensure exceptions to the global audit plan are properly documented, justified, and approved.
Stay abreast of current and updated regulations affecting the Audit program and modify the plan, policies, and directives to ensure appropriate compliance with changing regulatory requirements.
Maintain and continuously improve governing procedures and processes.
Develop and utilize robust metrics and analysis to monitor the health and performance of the Audit program, enhance audit planning, maximize audit effectiveness, and measure outcomes/impacts of audits.
Elevate and refine the audit program through vigilant monitoring and data-driven insights in partnership with Competitive Compliance.
Utilize internal processes such as Quality Risk Management (QRM) and the Quality Council to communicate signals and trends, mitigate risks, and drive continuous improvement.
Obtain business support to address supplier audit scheduling issues, including audit refusals and audit fees.
Qualifications & Experience
Minimum of five (5) years' experience in biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory role or a combination thereof and/or experience working with a regulatory health authority. High-level understanding of auditing, metrics, analysis, and Business Analytics.
Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.
Proven ability to understand complex processes/problems and propose alternate solutions.
Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.
Ability to work in a matrixed organization with diverse teams and influence areas not under direct control to achieve objectives and effectively communicate challenging goals.
Able to manage multiple, simultaneous projects with minimal supervision and prioritize work.
In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
Proven track record of collaborating across the network to find common solutions and drive positive impact for patients.
Strong understanding of performance/health program monitoring and data quality assurance principles.
Ability to communicate and collaborate with employees and management at all levels through various formats (presentations, proposals, reports, meetings, etc.).
Proficiency in data analytics and advanced analytics tools.
Note : This description reflects the responsibilities and qualifications for the role and does not include unrelated postings or site-specific notices.
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Senior Manager, Audit Intelligence Coordinator
role at
Bristol Myers Squibb .
Position summary
Reporting to the Senior Director, Operations & Performance, the Senior Manager, Audit Intelligence Coordinator is responsible for planning audits in support of the BMS Competitive Compliance Audit Program. This includes coordinating audits for internal sites, global suppliers, and entities such as CMOs, APIs, raw materials, and external labs. This role involves planning, organizing, and scheduling audit assignments in accordance with the global audit plan. It also supports clinical and commercial business developments through due diligence audits and communicates any changes in the global audit plan to stakeholders and audit outsourcing partners. Utilizing data-driven insights, this role aims to enhance audit planning and execution, ensure the audit program's health and performance, and integrate with internal processes such as QRM and Quality Council.
Key Responsibilities
Develop and implement an annual audit plan using risk-based principles and data-driven decision-making.
Plan, organize, and schedule audit assignments in collaboration with Audit Operations, in accordance with the defined audit program and audit plan.
Work with key stakeholders to maintain and update the annual audit plan for both planned and unplanned changes including routine, due diligence audits, pre-approval inspection readiness, directed or for-cause audits, acquisitions, regulatory/agent distributors, labeling and inspection readiness.
Enhance efficiency and simplify the management of the audit planning process by leveraging digital solutions such as automation and AI to advance strategic initiatives and focus on high-impact areas.
Communicate with stakeholders, Audit Operations, lead auditors, and audit outsourcing partners regarding global audit plan changes in a timely manner.
Periodically review and update the audit plan using current compliance, quality, data intelligence, and risk-based principles.
Ensure exceptions to the global audit plan are properly documented, justified, and approved.
Stay abreast of current and updated regulations affecting the Audit program and modify the plan, policies, and directives to ensure appropriate compliance with changing regulatory requirements.
Maintain and continuously improve governing procedures and processes.
Develop and utilize robust metrics and analysis to monitor the health and performance of the Audit program, enhance audit planning, maximize audit effectiveness, and measure outcomes/impacts of audits.
Elevate and refine the audit program through vigilant monitoring and data-driven insights in partnership with Competitive Compliance.
Utilize internal processes such as Quality Risk Management (QRM) and the Quality Council to communicate signals and trends, mitigate risks, and drive continuous improvement.
Obtain business support to address supplier audit scheduling issues, including audit refusals and audit fees.
Qualifications & Experience
Minimum of five (5) years' experience in biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory role or a combination thereof and/or experience working with a regulatory health authority. High-level understanding of auditing, metrics, analysis, and Business Analytics.
Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.
Proven ability to understand complex processes/problems and propose alternate solutions.
Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.
Ability to work in a matrixed organization with diverse teams and influence areas not under direct control to achieve objectives and effectively communicate challenging goals.
Able to manage multiple, simultaneous projects with minimal supervision and prioritize work.
In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
Proven track record of collaborating across the network to find common solutions and drive positive impact for patients.
Strong understanding of performance/health program monitoring and data quality assurance principles.
Ability to communicate and collaborate with employees and management at all levels through various formats (presentations, proposals, reports, meetings, etc.).
Proficiency in data analytics and advanced analytics tools.
Note : This description reflects the responsibilities and qualifications for the role and does not include unrelated postings or site-specific notices.
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