Senior Manager, Risk & Compliance
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Job Description
Sr Manager Risk & Compliance ensuring compliance in facility management for J&J across regions. Managing risks, compliance systems, and supporting internal audits in diverse operational environments.
Responsibilities:
- 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
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