[Hiring] Senior Manager Risk & Compliance @Johnson & Johnson Innovative Medicine

Role Description

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Engineering & Property Services (E&PS), we take care of all J&J buildings around the world providing end to end services from Real Estate, Engineering & Strategic Project Delivery to Facilities Management. We have a profound influence on the entire J&J Enterprise, providing innovative workplaces where our employees can collaborate and grow, and delivering flexible site solutions which enable our business to best serve our important customers and patients.

The Sr Manager Risk & Compliance is accountable for delivering standardized and consistent FM services within a distinct region while driving deep alignment with J&J Quality functions per segment and per region, EHS&S, Regional Leads, Sub-Regional Leads, and suppliers. This role is responsible for supporting compliance throughout the entire facilities portfolio to ensure adherence to applicable policies, procedures, and regulations.

The individual will also act as a “Global Single Point of Contact” and collaborate with the Global Make Quality organization for a nominated Segment. This individual will also collaborate with outsourced suppliers to complete auditing activities.

Key Responsibilities

• Regional Risk Compliance and Quality:
  • 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
  • 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
  • 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
  • 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
  • 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
  • Champion cross-regional coordination to deliver outstanding quality, establish standard methodologies, and implement J&J worldwide policies and standards
  • Use relevant quality reporting tools for each segment, providing a regional and segment overview and status of compliance metrics
  • Participate in workshops to identify, assess and determine responses to risks
• Global Single Point of Contact (SPOC) for Segment Make Quality:
  • Serve as the Global SPOC for Make Quality compliance relating to facilities responsible requirements with a nominated Segment
  • Proactively engage and partner with the Global Make Quality function of the assigned segment
  • Collaborate and align with Make Quality for the assigned segment and peer Regional Risk, Compliance and Quality leads
  • Act as SME and Global Facilities interface for segment specific Quality and compliance databases, tools, applications, tracking and reporting mechanisms
  • Proactively partner with the assigned segment Make Quality function to ensure all facilities compliance data for that segment is accurate
  • Participate in workshops to identify, assess and determine responses to risks

Qualifications

• Bachelor’s degree or equivalent required
• Bachelor’s degree or equivalent in related field (engineering, science, business, etc.) preferred
• Master's degree, in related field (operations management, finance, engineering, architecture, real estate, facilities management, or business administration), or equivalent preferred

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

Preferred Skills

• 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

Travel Requirements

• This position will require up to 25-50% domestic and international travel