The Leader, Manufacturing & Labs Technology Compliance is responsible for leadership, development, execution and continuous improvement of J&J Technology Quality & Compliance (JJTQ&C) global compliance programs. This position is accountable for oversight of, and contributing to the execution of, closed loop audit and assessment programs, including Technology Supplier Audit and GxP system Periodic Reviews. The position will be responsible for providing inputs to TRC risk assessment processes and informing future state audit processes based on data-driven analysis. The individual will build business knowledge and proactive relationships with process area stakeholders, business owners and TQ&C leads. This position is responsible for monitoring and interpreting new/changing regulations and providing direct support to business segments during global health authority inspections and other third-party audits related to Technology areas. This position is responsible for compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. This position provides strategic compliance subject matter expertise to quality, operations and business partners, across a broad range of technology related areas and is responsible for developing compliance strategies that meet regulatory requirements, while enabling innovation. In addition, this position requires the identification and communication of any potential GxP compliance and or quality issues.

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 follow-up 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.

Stakeholder Management, Compliance Expertise and Support for Base Business and Innovation Initiatives

Provides compliance subject matter expertise and support to Technology Quality and sector Business Partners related to GxP processes in the end-to-end technology areas under their responsibility.
Maintain up-to-date and emerging knowledge of compliance processes and changes (real-time 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.
Executes technology inspection readiness and support program, including providing support to J&J Operating Companies globally and preparing technical subject matter experts to interface with regulators. Strategizes the approach for regulatory interactions and engages directly with health authority agencies during inspections. Leads the development of responses to Technology owned health authority observations.
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) sub-pillar.
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 submit final comments through the appropriate channel.
Leads the development and delivery of education and training on compliance requirements, procedures and controls to key stakeholders

Other

Develops and maintain an effective working partnership with senior management.
Mentors talent and helps them grow in their careers.
Collaborates with other leaders and staff within Technology Quality & Compliance to ensure each function is executed in an efficient manner.
Ensures timely reports of status, metrics and time sheets as required by the Technology Quality & Compliance organization
Ensures timely completion of assigned training and expense reports.
Supports JJRC enterprise initiatives, including execution of JJRC independent audit program, projects, and special assignments.
Reviews and provides input to J&J quality and/or technical standards

Qualifications

7+ years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
Auditor experience in a regulated industry, preferably HealthCare Industry
Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
Experience interpreting regulations and translating regulatory requirements into practical strategies.
Ability to resolve complex regulatory compliance issues.
Ability to analyze and interpret regulatory documents.
Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations.
Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
Ability to effectively present information to executive management.
Ability to lead teams and build strong cross-functional relationships.
Ability to influence, negotiate, and build credibility.
Strong skills in interdependent partnering to facilitate collaboration.
Audit management and delivery
Analytical mindset

Preferred

Expertise in medical device quality, including standards for medical device software development and risk management preferred (e.g., ISO, IEC, AAMI)
Experience in regulatory affairs areas, including knowledge of 510K and PMA submission process (or global equivalent).
Experience in establishing Quality Management Systems.
Auditor experience.
Project Management
Data analysis and reporting
Risk-based audit framework development and execution
Audit logistics coordination