Leader, Manufacturing
il y a 2 semaines
Division/ Department:
J&J Technology Regulatory Compliance (Q&C)**:
Main responsibilities:
Risk-Based Closed Loop Supplier Audit and Periodic Review Programs
- Owns, manages, and executes closed loop Supplier Audit and GxP System Periodic Review Programs, including conducting independent audits/reviews, providing independent oversight of audit planning, execution and tailored assessment/fieldwork approaches, audit and assessment corrective actions, documenting results, reporting on followup status, escalating critical issues/risk to senior leadership, performing trend analysis, and continuously improving program effectiveness.
- Plan, organize and execute comprehensive audits of GxP software and/or software technology service providers such as suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS), encompassing the entire computerized system lifecycle to assess compliance with appropriate health authority regulations, guidances, company procedures and industry standards
- Partners with TRC Operations and contributes content for the development of procedures, schedules and resourcing.
- Negotiate alignment and secure support for audit and assessment remediation actions across Sector and functional groups
- Responsible for providing compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated technology are incorporated into the framework, executing on audit commitments and prioritizing processes as necessary to adjust schedule. Identify risks in current processes through data driven decision making and solutioning. Provides leadership and expertise in interpreting and evaluating risk associated with audit and health authority inspection findings and provides direction and support to Business and Quality groups in the development of corrective action plans that systemically address issues.
- Partners with Technology Quality and Business Quality to execute gap assessments between current practices and new regulatory expectations, as communicated via health authority regulations, guidance, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
- Maintains knowledge of strategic digital initiatives and major innovation programs across J&J globally and serves in a compliance strategy advisory capacity in the development of compliant pathways that meet regulatory requirements specific to business area under their E2E accountability
- Leads the resolution of complex situations that arise during execution of closed loop audit and assessment programs, including conflict resolution, articulates risks and impact, negotiates alignment and secures support for remediation actions that reduce risk.
- Coaches team on the planning/preparation, execution, field work focus and execution of corrective action verification activities, including status reporting, in support of closed loop audit programs.
- Maintain uptodate and emerging knowledge of compliance processes and changes (realtime occurring or imminent).
- Build and implement a relationship management plan to maintain consistent touchpoints with process area stakeholders, business owners, and TQ&C leads. Maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives and helps others to do the same.
- Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation. Identifies potential risks, articulates impact, and works with business partners to establish proactive risk mitigation strategies. Creates compliance strategies, including authoring position papers, to enable innovation in emerging areas.
- Interprets and communicates current and emerging regulations at a global level and continuously monitors the changing regulatory climate to proactively assess and communicate trends and emerging areas.
- Partners with Technology Quality, and business Sectors to ensure that J&J quality standards and global regulatory requirements are met and works with Quality and other partners to establish corrective actions to address any identified gaps and independently monitors and reports on the status of implementation
- Serves as a trusted partner across the Global Technology Quality & Compliance organization and directly manages relationships with relevant TQ systems and infrastructure assurance (S&IA) subpillar.
- Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions to strengthen compliance programs. Engages with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.
- Leads the development of meaningful comments to proposed regulations and guidance's and partners with key stakeholders to s
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