Senior Manager, Risk & Compliance

Role Overview

• Serve as single point of contact (SPOC) for compliance & risk-related issues in region
• Manage facilities risk and compliance systems, ensuring that all elements are in place to support the J&J worldwide policies and Facility Management Global standards
• Establish lines of engagement with the Regional segment Quality organization, EHS&S, and FM within region and in collaboration with peer Global segment SPOCs manage relationships with regional sector / platforms leads as Risk and Compliance SPOC in region
• Work with sub-regional, micro-regional and site FM roles, external outsourced vendors, SSG, Make Quality organization, and EHS&S to complete risk and quality compliance programs and resolve compliance issues
• Partner with Regional Leads, Sub-Region Leads, and Micro-Region Leads to support internal auditing program at the site level to identify risk and compliance issues; develop and implement corrective actions and track responses
• Establish external facilities partners audit program and manage inspection activities in conjunction with site management
• Review results of facilities-related investigations, non-conformances (NCRs), and events to understand the impact to the portfolio.
• Provide SME guidance, direction and support to the sub-regional leads in developing corrective action plans to address critical issues
• Ensure execution and on-going compliance of SOPs, protocols, change controls, validation reports, and trend reports for processes / systems across the region
• Develop training curriculum and requirements in partnership with internal quality team, EHS&S, SSG and local enforcement agencies
• Gather data for the development of Service Level Agreements covering technical or qualified operations and internal customers as appropriate
• Develop and lead the establishment, harmonization and on-going compliance of SOPs, protocols, change controls, validation reports and trend reports for the processes/systems of the entire facilities portfolio inclusive of business continuity management
• Champion risk, quality and compliance in the Regions to eliminate conflict of interest at Regional, Sub-Region, or Micro-Region level
• Provide consistency and visibility across supply chain and non-supply chain sites; introduce rigor of dedicated focus on risk & compliance
• Champion cross-regional coordination to deliver outstanding quality, establish standard methodologies, and implement J&J worldwide policies and standards.
• Conduct annual Regional quality reviews in coordination with Regional FM leadership, business partners, and segment Quality organizations to highlight concerns and opportunities for improvement
• Use relevant quality reporting tools for each segment, providing a regional and segment overview and status of compliance metrics.
• Provide regional support for sites for audits by internal functions and external regulatory agencies (e.g. FDA, MAARS, EHSS Comprehensive Audit, ISO, etc.)
• Participate in workshops to identify, assess and determine responses to risks

Requirements

• Minimum of 10 years of risk management or related experience.
• Including compliance management.
• Strong communication skills, both written and oral
• Ability to focus strategically while maintaining a tactical focus
• Ability to adapt emerging approaches and industry innovations
• Ability to lead diverse teams through change and to form strong relationships with regional / COE partners
• Strong understanding of risk, quality and compliance system
• Experience in medical devices, pharmaceutical, biologics, or other regulated industry
• Computer skills, including working knowledge of MS Office Suite
• Professional certifications (Six Sigma, SPC, Lean, Process Excellence, ISO/ICE 2000, etc.)
• Broad-based corporate facilities experience or equivalent, especially within a global corporation
• Knowledge of FDA GMPs, federal, and state environmental regulations, and/or ISO standards
• Audit experience with FDA or other external regulatory body
• Proficiency: English language

Benefits

• inclusive work environment
• Professional development opportunities