Johnson & Johnson Careers
Senior Manager Risk & Quality
Requisition ID: 1905727167W
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 129 years. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $75 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.
The Risk, Compliance & Quality role will be based regionally and be accountable for delivering standardized and consistent FM services within a distinct region while driving deep alignment with Global FM Q&C, J&J Quality and Risk functions per segment and per region, EHS&S, Regional Leads, Sub-Regional Leads, and suppliers. This position is responsible for supporting risk management, quality & compliance throughout the entire facilities portfolio to ensure adherence to applicable policies, procedures, and regulations. The individual will act as a “Global Single Point of Contact” and interface with the Global Make Quality organization for a nominated Segment. This individual will also collaborate with outsourced suppliers to execute auditing activities. An ideal candidate for this role will have demonstrated experience in risk management, quality and compliance management in an operational environment along with executing strategy within a robust, mission driven, and largely outsourced facilities organization across supply chain and non-supply chain sites.
Key relationships include communication and coordination with FM regional leads as appropriate, the leadership within the Enterprise Risk &Quality functions including the Make Quality function, the Supplier Risk & Quality function, EHS and Supplier Strategy & Governance to ensure successful implementation and management of the EFM program across regions while managing nuances of unique sub-regions.
Regional Risk Compliance and Quality:
• Serve as single point of contact (SPOC) for compliance & risk-related issues in region
• Regional FM individual accountable for R&Q program deployment.
• Manage facilities risk and compliance systems, ensuring that all elements are in place to support the J&J worldwide policies and standards established by Global FM R&Q
• Work with Global FM R&Q, internal sub-regional, micro-regional and site FM roles, external outsourced vendors, SSG, Make Quality organization, and EHS&S to execute risk and quality compliance programs and resolve compliance issues
• Partner with FM Global R&Q , Regional Leads, Sub-Region Leads, and Micro-Region Leads to execute auditing program to identify risk and compliance issues; develop and execute 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 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, Global FM R&Q , 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 compli ance of SOPs, protocols, change controls, validation reports and trend reports for the processes/systems of the entire facilities portfolio inclusive of business continuity management.
• Support regional risk programs including Controlled Self Assessment analysis and trends
• Champion quality and compliance in the Regions to ensure harmonization of FM requirements t
• 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 superior quality, establish best practices, and execute J&J worldwide policies and standards established by Global FM R&Q Conduct annual quality reviews in coordination with Regional EFM leadership, business stakeholders, and segment Quality organizations to highlight concerns and opportunities for improvement
• Utilize 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, ISO, etc.)
• Serve as the Global SPOC for Make Quality compliance relating to facilities responsible requirements with an assigned Segment and collaborate with their peer Regional Compliance and Quality leads to ensure all segment quality programs are executed and supported.
• Proactively engage and partner with the Global Make Quality function of the assigned segment to fully understand, influence and align the segment’s Make Quality strategies, policies, procedures and standards relating to facilities compliance with our Global Facilities execution programs and priorities.
• Proactively partner with the assigned segment Make Quality function to ensure all facilities compliance data for that segment is accurate, current and correctly reflects the compliance status of the Global Facilities function on our sites. Where reporting and/or data accuracy issues exist collaborate with Segment organization, peer Regional Risk, Compliance and Quality leads and Regional Leads to ensure data accuracy is maintained. -
• Bachelor’s degree or equivalent required; 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 strongly preferred
• Minimum of 8-10 years of risk management / quality compliance management or related experience is required
• Professional certifications (Six Sigma, SPC, Lean, Process Excellence, ISO/ICE 2000, etc.) preferred
Knowledge, Skills and Abilities:
• Broad-based corporate facilities experience or equivalent, especially within a global corporation; preferred
• Strong communication skills, both written and oral; required
• Ability to focus strategically while maintaining a tactical focus; required
• Ability to adapt emerging best practices and industry innovations; required
• Ability to lead diverse teams through change and to form strong relationships with regional / COE partners; required
• Ability to form strong relationships with business partners; required
• Knowledge of risk management strategies and practices.Knowledge of FDA GMPs, federal, and state environmental regulations,
and/or ISO standards; preferred
• Strong understanding of quality and compliance system; required
• Experience in medical devices, pharmaceutical, biologics, or other regulated industry; preferred
• Audit experience with FDA or other external regulatory body; preferred
• Computer skills, including working knowledge of MS Office Suite; required
• Must be able to travel regularly between sites, up to 25-50% of time
Janssen-Cilag S.p.A. (7175)