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Senior Manager, IT Regulatory Compliance
Requisition ID: 7147180327
Johnson & Johnson is recruiting for a Senior Manager, IT Regulatory Compliance to be located in Raritan, New Jersey.
Johnson & Johnson Family of Companies, caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $74.3 billion in 2014 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
The Senior Manager, IT Regulatory 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 leading GxP computer system reviews and Software as a Medical Device (SaMD) product assessments; monitoring and interpreting of new/changing regulations; supporting health authority inspections; and contributing to the execution of internal audits and technology supplier audits. This position also provides strategic compliance subject matter expertise to quality and operations partners, across a broad range of technology related areas, including medical device software and digital product development.
This position reports solid line to the Director, IT Regulatory Compliance, within the Johnson and Johnson Regulatory Compliance (JJRC) organization.
- Own, manage, and execute Audit Programs, including authoring procedures, developing schedules and resourcing, conducting independent audits/reviews, documenting results, reporting on follow-up status, escalating critical issues/risk to senior leadership, and continuously improving program effectiveness.
- Provide leadership and expertise in interpreting and evaluating risk associated with audit findings and provides direction and support to Business and Quality groups in the development of corrective action plans that systemically address issues.
- Partner with Technology 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.
- Serve as compliance partner and key advisor to Technology Services and Technology Q&C related to GxP processes in the areas of software development, across a broad portfolio covering GxP applications, Software as a Service (SaaS), Software as a Medical Device (SaMD), Mobile Medical Apps (MMaps), and other Health software digital products.
- Partner 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.
- Execute technology inspection readiness program, including providing support to J&J Operating Companies globally and preparing technical subject matter experts to interface with regulators. Engages directly with health authority agencies during inspections. Leads the development of responses to Technology owned health authority observations.
- Interpret and communicate current and emerging regulations at a global level and continuously monitors the changing regulatory climate to proactively assess and communicate trends and emerging areas.
- Participate in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions in order to strengthen compliance programs.
- Engage with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.
- Lead the development of industry comments to proposed regulations and guidances and partners with J&J Regulatory Compliance Regulatory Outreach (ERO), Regulatory Affairs, and others to submit final comments through the appropriate channel.
- Lead the development and delivery of education and training on compliance requirements, procedures and controls to key stakeholders
- Support the deployment of an enterprise Q&C Healthcare Technology Strategy.
- A bachelor’s degree and a minimum of 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.
- A focused degree in science, IT, engineering, business or QRC discipline is highly preferred.
- 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 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 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.
- Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing is required.
- Ability to effectively present information to executive management is required.
- Ability to lead teams and build strong cross-functional relationships is required.
- Ability to influence, negotiate, and build credibility is required.
- Strong skills in interdependent partnering to facilitate collaboration is required.
- Expertise in medical device quality, including standards for medical device software development and risk management preferred (e.g., ISO, IEC, AAMI) is preferred.
- Experience in regulatory affairs areas, including knowledge of 510K and PMA submission process (or global equivalent) is preferred.
- Experience in establishing Quality Management System is preferred.
- People management experience is preferred.
- Auditor experience is preferred
- This position will be located in Raritan, New Jersey and may require up to 20 % domestic and/or international travel.
United States-New Jersey-Raritan
Johnson & Johnson Services Inc. (6090)