Lead, Technology Compliance

1 week ago

Raritan, New Jersey, United States Johnson & Johnson Full time
Johnson & Johnson Services Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead, Technology Compliance, located in Raritan, NJ

The Lead, Technology Compliance is responsible for providing operational support for the execution of Enterprise Quality Compliance Programs.


This position is responsible for supporting audit and assessment corrective actions as part of closed loop audit and assessment programs, including Technology Supplier Audit and GxP System Periodic Review.

This role is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas; and compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate.

This position assists in the continuous improvement of the compliance programs, including external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions

Key Responsibilities:

  • Leads and performs closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech and Enterprise) GxP computerized systems that are supported by Enterprise Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.
  • Leads and performs closed loop supplier audits, covering GxP related software and service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS).
  • Assists in providing independent oversight of audit and assessment corrective actions, documenting results, reporting on followup status, raising any identified risk, and assisting with the continuous improvement of the followup program.
  • Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Enterprise Quality related inspection requests and preparing domain experts to speak with investigators.
  • 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.
  • Maintain awareness of new and emerging technologies and regulatory requirements.

Qualifications:

Education:

  • A Bachelor degree or equivalent in Science, IT, Quality, Mathematics, Engineering or Business Administration is required.

Experience and Skills:

Required:

  • A minimum of five (5) years of experience in coordinating all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
  • Experience in information systems and/or GxP auditing within Pharmaceutical/Medical Device company or minimum of 2 years of direct experience with GxP Quality Assurance, development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company.
  • Experienced knowledge of GMP Manufacturing QA, GAMP5, data integrity requirements.
  • Experience interpreting regulations and translating regulatory requirements into practical strategies.
  • Demonstrable ability to support complex projects, priorities and multiple tasks and demonstrated experience in writing compliance documentation and ability to analyze and interpret regulatory documents.
  • Excellent verbal and written communication skills.
  • Ability to influence, negotiate, inspire trust, and quickly build credibility to enable the achievement of mutual goals, including solid skills in interdependent partnering to facilitate collaboration as well as partner and team coordination.
  • Ability to perform work with a high degree of independence and demonstrable experience in driving progress and remaining focused under ambiguous and complex situations while working effectively in a virtual team environment.

Preferred:

  • Expertise in medical device software quality requirements, including standards for medical device software development and risk management preferred.
  • Experience working with Quality Management Systems.
  • Auditor experience. 2+ years of experience with auditing, Risk Assessment and Management and Nonconformance/CAPA system in a regulated industry, preferably Health Care Industry.
  • Experience effectively working with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc.
  • Audit management and delivery.
  • Riskbased audit framework development and execution.

Other:

  • This position will be located in Raritan, NJ and may require up to 10% domestic or international travel.
The anticipated base pay range for this position is $90,000 to $144,900.

  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short
- and long-term disability, business accident insurance, and group legal insurance.

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