Johnson & Johnson is currently recruiting for an IT Lead, Regulatory Compliance. This position will be located in Raritan, NJ.
Johnson & Johnson, through its operating companies, 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. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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 or 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.
The IT Lead, Regulatory Compliance will:
- Execute follow-up activities for new or 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.
- Provide compliance support to innovation initiatives and key projects.
- Partner with stakeholders to assess, develop, and implement solutions that enable compliant innovation. Identifiy potential risks, articulate impact, and work with business partners to establish proactive risk mitigation strategies.
- 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.
- Work with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provide 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.
- Support Health Authority inspection readiness activities.
- Contribute to the content for writing SOPs, WIs and Policies for compliance programs.
- Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders 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.
- When applicable, lead the delivery of education and training on compliance requirements, procedures and controls.
- Bachelor’s Degree in Information Technology, Computer Science, or any other Scientific or Technical field required.
- Minimum of 3 years of experience in Quality and Regulatory Compliance global and regulated healthcare environment
- 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 required.
- Experienced with IT internal controls, SDLC methodologies, GAMP5, and data integrity requirements required.
- Experience interpreting regulations and translating regulatory requirements into practical strategies required.
- Demonstrated experience in writing compliance documentation as well as the ability to analyze and interpret regulatory documents is required.
- Demonstrated ability to support complex projects, priorities and multiple tasks
- Excellent verbal and written communication skills and the ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals.
- Strong skills in interdependent partnering to facilitate collaboration and the ability to work effectively in a virtual team environment.
- Ability to perform work with a high degree of independence and proven experience in driving progress and remaining focused under ambiguous and complex situations.
United States-New Jersey-RaritanOrganization
Johnson & Johnson Services Inc. (6090)Job Function
Info TechnologyRequisition ID