VP, Quality Systems, Innovative Medicine (Belgium/Ireland)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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Job Description:

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

• USA (Raritan, Titusville, New Brunswick, Horsham) Req #: R-029355
• Belgium (Beerse) Req #: R-029498
• Switzerland (Schaffhausen) Req #: R-029484
• Ireland (Cork) Req #: R-029498

Position Summary:

The Vice President Quality Systems is responsible for providing high-level strategic oversight and direction for quality initiatives across the organization, including QMS, process ownership, capa/escalation and lab systems as well as foundational quality governance through performance management. This role focuses on aligning quality systems with regulatory requirements and organizational objectives while fostering a culture of continuous improvement and operational excellence. The VP will work closely with various stakeholders to ensure the effectiveness of quality governance and its integration into the broader business strategy.

Key Responsibilities:

• Develop the strategic vision and roadmap for quality governance, ensuring alignment with overall quality and compliance objectives.
• Drive the transformation of governance strategies by implementing predictive analytics and advanced monitoring capabilities through a agenda that is clearly articulated and delivers value to the business.
• Oversee the end-to-end CAPA, escalation and investigation process to ensure it is working as intended and risks are being escalated as appropriate.
• Serve as a liaison to senior management and governance bodies, communicating emerging risks and QMS performance.
• Partner to deliver on Transcend initiative in conjunction with key business partners.
• Accountable for the overarching lab strategy and roadmap, including accountability for all lab systems and digital transformation programs
• Define key performance indicators (KPIs) to monitor compliance with quality governance standards and provide regular reports to leadership.
• Review and oversee the effectiveness of the Quality Management System (QMS) and its implementation across business units.
• Partner with Business Process Owners and key stakeholders to identify potential risk areas, developing strategies for remediation.
• Maintain expert knowledge of US and international regulations, ensuring adherence to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP) and pharmacovigilance standards.
• Lead, mentor, and develop a high-performing team focused on quality governance and compliance, promoting a culture of accountability and continuous learning.
• Champion and promote a culture of quality and operational excellence throughout the organization.
• Identify and implement continuous improvement initiatives that enhance the effectiveness of the QMS and governance processes.
• Maintain and manage the departmental budget, ensuring adequate resources are allocated to quality governance and compliance activities.
• This role will require interdependent partnering with both internal and external partners. He/she will function as the Key Interface with Q&C functional organizations within and across sectors. Key liaison to J&J Supply Chain Systems and Solutions group, J&J Technology and enterprise Quality Services group.
• He/she will also participate in internal and external working groups, industry groups and other influencing communities, to drive leveraging and learning and identify opportunities for improvements.

Required Minimum Education: Bachelor's Degree required. Preferred Area of Study: Life Sciences, Engineering, Supply Chain, Quality/Regulatory

Required Years of Related Experience: 15 years of experience in Quality Management Systems and/or Operations Management in a highly regulated industry (Pharmaceutical, Medical Device or similarly regulated industry)

Required Knowledge, Skills and Abilities:

• Deep knowledge of regulated healthcare environment and strong business aumen in Innovative Medicine (IM) environment including knowledge in industry regulations and cGMP
• 5+ years of people management experience
• Functional knowledge of / experience in Quality & Compliance.
• Demonstrated experience in Global Process Ownership across a complex multi-national healthcare company
• Knowledge of Process or Business Excellence, and analytical skills
• Experience working with Quality Systems is crucial (ie: Document Management, Change Control, Deviation and CAPA Management, etc.) at a process, platform, and execution level
• Direct and deep experience in leading Quality Systems Technology projects with demonstrated delivery of value; Experience preparing business cases and capital appropriation requests
• Comprehension of concepts related to data include analytics and automation
• Experience in designing, implementing, and maintaining governance models to ensure appropriate oversight and management of complex systems
• Incumbent must be able to document and demonstrate a strong business and strategic acumen
• Create a direct and indirect organization with a culture of global customer focus and the ability to deliver
• Strong blend of tactical and strategic management skills with ability to influence stakeholders.
• Demonstrated ability to establish and maintain effective working relationships with diverse groups of people in a global and matrixed organization
• Ability to influence others, managing competing internal stakeholder priorities and dealing with ambiguity.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally
• Outstanding communications skills (including articulating product vision, inspiring teams, and presenting to senior executives)
• The candidate must be able to uphold our Credo Values, while driving innovation with a customer focus mentality

Preferred Knowledge, Skills and Abilities:

• Experience in Innovative Medicine (IM)
• Experience in Supply Chain, Commercial, and/or R&D is preferred
• Experience with Six Sigma/Process Excellence tools, training and certification is preferred.
• Organizational change management experience
• Quality Application system IT experience (design, build, validate, deploy, maintain)
• Project Management experience, to include resource management, FTE demand, risk analysis, cost optimization
• High level of proficiency in J&J applications & technologies (QS, Office & productivity tools)
• Compliance with the GxP, EHS and SOX requirements and guidelines, which are connected to the respected function