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Lead, IT Regulatory Compliance.

Company: Johnson & Johnson
Location: Raritan
Posted on: November 19, 2021

Job Description:

Johnson & Johnson is recruiting for a Lead, IT Regulatory Compliance located in Raritan, NJ.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.1 billion in 2020 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 markets. 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.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

This role provides operational support for the implementation and execution of IT Services (ITS) and Q-CSV Center of Excellence (CoE) compliance programs, including conducting remediation follow-ups related to new/changing regulations; health authority commitments; and corrective actions to internal audit, supplier audit, and computerized system periodic reviews. This position is responsible for providing tactical GxP compliance support to base business and innovation initiatives, including healthcare technology and digital health related projects to ensure inspection readiness and effectiveness of remediation action plans. This position must ensure that J&J quality standards and global regulatory requirements are met and must drive the maintenance and continuous improvement of compliance programs within budget and with high quality.

Key Responsibilities

Compliance Programs
Leads and carries out follow-up activities for new/changing regulation gap closure; health authority observation commitments; internal audits; supplier audits; and computerized system periodic reviews, including verification of remediation commitments, documentation of results, reporting on follow-up status, and escalation of any identified risk.
Support the continuous improvement of 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.
Works with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides compliance support to ensure the development of robust corrective action plans that address the root cause of issues.
Perform gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidance, and enforcement trends. Work with Quality partners to establish corrective actions to address any identified gaps.

External Regulatory Outreach and Communication
Builds and maintains trusting, collaborative relationships and partnerships with internal and external partners to accomplish business objectives.
Maintain awareness of new and emerging technologies and regulatory requirements
Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
Assist in the development of content and maintenance of the ERO IT Topics page.
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.
Support the communication of current and emerging regulatory requirements and trends to internal partners, in coordination with JJRC Enterprise Regulatory Outreach (ERO), and proactively initiates gap assessments to new requirements.

Compliance Expertise and Support
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.
Support Health Authority inspection readiness activities. Ensuring technical subject matter expert preparedness on matters related to IT processes, computer system validation, and other technical topics.
When applicable, leads and/or supports the delivery of education and training on compliance requirements, procedures and controls.

Provides compliance support to innovation initiatives and key projects.

Qualifications
Minimum of a bachelor's degree is required
Minimum of 6 years of professional related experience is required
A minimum of 3 years of experience in leading all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment is required
Experienced 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
Experienced knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements is required
Experience interpreting regulations and translating regulatory requirements into practical strategies is required
Demonstrated experience in writing compliance documentation is required
Ability to analyze and interpret regulatory documents are required
Must possess demonstrated ability to support complex projects, priorities and multiple tasks
Excellent verbal and written communication skills are required
Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals is required
Solid skills in interdependent partnering to facilitate teamwork required
Ability to perform work with a high degree of independence and demonstrable experience in driving progress and remaining focused under ambiguous and complex situations is required
Ability to work optimally in a virtual team environment is required
Expertise in medical device software quality requirements, including standards for medical device software development and risk management preferred.
Experience working with Quality Management Systems is preferred
Auditor experience. 2+ years of experience with auditing, Risk Assessment and Management and Nonconformance/CAPA system in a regulated industry, preferably HealthCare Industry, is preferred
Knowledge of process design, development and continual improvement is desired
Experience effectively working with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc. is preferred
This position will be located in Raritan, NJ and may require up to 10% travel

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.

Primary Location

United States-New Jersey-Raritan-1003 US HIghway 202

Organization

Johnson & Johnson Services Inc. (6090)

Job Function

Info Technology

Requisition ID

2105981128W

Keywords: Johnson & Johnson, Trenton , Lead, IT Regulatory Compliance., Accounting, Auditing , Raritan, New Jersey

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