Johnson & Johnson is recruiting for a Senior Manager, IT Regulatory Compliance. The position will be based in Raritan, NJ.
The Senior Manager, IT Regulatory Compliance is responsible for leadership, execution and continuous improvement of IT Services (ITS) and Q-CSV Center of Excellence (CoE) compliance programs. This position is accountable for remediation follow-up programs related to new/changing regulations; health authority commitments; and corrective actions to internal audit, supplier audit, and computerized system periodic reviews. This position is accountable for Health Authority inspection readiness and support, including expanding program coverage into emerging healthcare technology / digital health areas. This position is responsible for providing compliance subject matter expertise to quality and operations partners, across a broad range of technology related areas, including medical device software development, and for ensuring that compliance requirements are embedded into innovation initiatives.
Major Responsibilities include:
• Owns, manages, and executes Compliance Follow-Up Programs, including authoring procedures, developing schedules and resourcing, conducting independent remediation verification activities, documenting results, reporting on follow-up status, escalating any identified risk, and continuously improving program effectiveness.
• Works with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides compliance subject matter expertise to ensure the development of robust corrective action plans that address the root cause of issues.
• Partners with IT Q&C and Q-CSV CoE to execute gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidances, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
• Owns and continuously improves ITS and Q-CSV CoE compliance programs associated with remediation follow-up activities for new regulation gap closure; health authority observation commitments; internal audits; supplier audits; and computerized system periodic reviews.
•Owns Health Authority inspection readiness and support program related to software applications, including authoring procedures and ensuring development of inspection front room story boards. Ensures continuous expansion of program to cover emerging areas, such as medical device software development and digital health.
•Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand ITS and/or Q-CSV related inspection requests and preparing technical subject matter experts to speak with investigators.
•Engages directly with health authority inspectors from regulatory agencies and assists/accompanies technical subject matter experts to engage with regulators as needed.
•Drives development of formal responses to health authority observations and conducts final response review before submission.
•Provides compliance subject matter expertise and support to IT Services and the Q-CSV CoE related to GxP processes in the areas of software and medical device development, across a broad portfolio covering Software as a Service (SaaS), Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps).
•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.
•Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions in order to strengthen compliance programs. Engages with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.
•Works with key stakeholders to develop meaningful comments to proposed regulation and guidances and partners with ERO, Regulatory Affairs, and others to submit final comments through the appropriate channel.
•Leads the development and delivery of education and training on compliance requirements, procedures and controls.
•Supports the development and deployment of a JJRC wide Healthcare Technology Strategy.Qualifications
•A minimum of a Bachelor's Degree in Science required with a focused degreed in IT, Engineering, Business, and Quality & Regulatory Compliance related discipline is preferred.
•A minimum 7 years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment is required.
•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 is required.
•Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements is required.
•Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc. is required.
•Experience interpreting regulations and translating regulatory requirements into practical strategies is required.
•Ability to lead teams and build strong cross-functional relationships is required.
•Ability to influence, negotiate, and build credibility is required.
•Ability to resolve complex regulatory compliance issues is required.
•Ability to analyze and interpret regulatory documents is required.
•Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations is required.
•This position will be based in Raritan, NJ and requires up to 20% domestic and international travel.Primary Location
United States-New Jersey-RaritanOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function