J&J Family of Companies Senior Manager, Technology Regulatory Compliance in Pierre, South Dakota
Johnson & Johnson Technology Quality & Compliance is recruiting for a Senior Manager, Technology Regulatory Compliance. Ideally located in Raritan NJ. Will consider other North America location close to a J&J business site.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
The Senior Manager, 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 rapidly growing 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.
This position will manage direct reports.
This position reports solid line to the Director, Technology Regulatory Compliance, within the Johnson and Johnson Technology Quality & Compliance organization.
• 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, raising any identified risk, and continuously improving program effectiveness.
o 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.
o 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.
o Works with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides council to ensure the development of corrective action plans that address the root cause of issues.
Inspection Readiness and Support:
• 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.
Compliance Expertise and Support for Base Business and Innovation Initiatives:
• 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.
• 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.
• 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.
• Bachelors’ degree required. A focused degree in science, IT, engineering, business or Quality & Regulatory Compliance discipline is highly preferred.
• Minimum 8 years of progressive experience in Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment required.
• Previous supervisor/people management experience 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 required.
• Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements required.
• Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc required.
• Experience interpreting regulations and translating regulatory requirements into practical strategies required.
• Expertise in medical device quality, including standards for medical device software development and risk management preferred.
• Experience in establishing Quality Management Systems preferred.
• Auditor experience preferred.
• Ability to resolve complex regulatory compliance issues required.
• Ability to analyze and interpret regulatory documents required.
• Proven experience in driving progress to strategic plans and remaining focused under ambiguous and complex situations required.
• Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing required.
• Ability to effectively present information to executive management required.
• Ability to lead teams and build strong cross-functional relationships required.
• Ability to influence, negotiate, and build credibility required.
• Strong skills in interdependent partnering to facilitate collaboration required.
• Travel 10 % includes Domestic (US) And International
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
North America, North America-Canada, North America-United States
Johnson & Johnson (6067)
J&J Family of Companies
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