Staff Regulatory Compliance Engineer
Johnson & Johnson Innovative Medicine
Summary
Maintain a robust Compliance program to ensure compliance with all applicable quality system and regulatory requirements, company policies and procedures, and J&J Corporate requirements.
Job description
Audit Program Management
- Manage External and Internal Audit Program and Management Execution.
- Execute external and internal audits according to the established audit procedures.
- Ensure external and internal audit results are reported to management having responsibility for the matters audited.
- Carry out and lead external and internal audit and inspection readiness activities to ensure site readiness at all times including audit logistics, from room/back-room arrangements, identifying and preparing SME's, etc.
- Strategically support management of external and internal audits/inspections of the site.
Corrective Actions and Risk
- Provide guidance to ensure timely and adequate responses to internal and external audit observations, including failure investigations, root cause analysis, risk assessments, correction, corrective and preventive action plans.
- Monitor and drive on-time completion of all action plans, perform follow-up with owners, and perform effectiveness monitoring and closure.
- Assure that internal and external audit metrics are accurately captured and published.
- Create reports and communicate performance against metrics to key stakeholders.
- Highlight and communicate adverse trends in metrics and take risk-based action to remediate.
Regulatory and Quality Systems
- Monitor and lead implementation of new and revised regulations and standards for the site.
- Apply comprehensive and diverse knowledge of quality systems in work assignments, projects and initiatives.
- Lead projects to ensure compliance with quality system and regulatory requirements.
- Act as emerging authority in the regulatory compliance field.
- Connect and collaborate with the regulatory compliance teams of other sites, regions, and business groups to attain common objectives.
- Provide input into Site Management Reviews and Data Review Boards (e.g., internal audits.) to allow meaningful reviews.
- Establish strong connection and collaboration with business partners at the site, e.g. Quality Operations, Training, and Manufacturing.
- Provide/coordinate regulatory compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational/training strategies.
People Leadership
- Perform performance appraisals and establish goals/objectives and development plans for direct reports.
- Comply with all environmental, safety and occupational health policies and ensure all direct reports comply with those requirements.
Requirements
- Bachelor's degree in Pharmaceutical Sciences, Industrial Management and Engineering, or related field
- 8 years of experience in the job offered or in a Staff Regulatory Compliance Engineer-related occupation
- Experience in medical device or pharmaceutical industry including regulations, standards, and Federal and Local authority requirements
- Experience with Quality Management Systems (QMS) / audit-tracking software including Truvault, Windchill, VEEVA, Trackwise, ETQ, SAP, Maximo, IRIS, or OURSOURCE
- Experience with FDA QSR, EU MDR and IVDR
- Experience with GMP, QSR, ISO standards including ISO 13485
- Experience in regulatory change implementation and interpreting new/revised regulations and translating them into site-level controls and procedures
- Experience in internal audit program management including planning, executing and reporting internal audits and ensuring closure and tracking of findings
- Experience in corrective action and problem solving, CAPA management, Root cause analysis and structured RCA techniques including 5 Whys, Fishbone, or Ishikawa
- Experience performing risk assessments and applying risk-based prioritization including FMEA and risk registers
- Experience with data analysis and analytics reporting tools including Power BI
- Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) or Lead Auditor certification
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Pension Plan
- 401(k) Savings Plan
- Long-term Incentive Program
- Vacation
- Sick Time
- Holiday Pay
- Parental Leave
- Bereavement Leave
- Caregiver Leave
- Volunteer Leave
- Military Spouse Time-Off
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.