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-032095
• Belgium (Beerse) Req #: R-032625
• Switzerland (Schaffhausen) Req #: R-032615
• Ireland (Cork) Req #: R-032625

Position Summary

The Senior Director, Quality Governance, is responsible for leading the governance framework that ensures quality and compliance across the organization. This role focuses on establishing and maintaining quality governance standards, policies, and processes that align with regulatory requirements and organizational goals. The incumbent will foster a culture of quality and compliance, providing strategic oversight to ensure operational excellence throughout all quality-related functions.

Responsibilities

• Establish and oversee a comprehensive governance framework for quality that aligns with industry regulations, corporate policies, and best practices.
• Design and implement quality governance policies, processes, and standards across the organization to ensure compliance and operational effectiveness.
• Ensure compliance across the Quality Management System (QMS) through proactive analysis of actionable metrics to identify potential risks and opportunities for advancement.
• Guide coordination and execution of various governance bodies such as Quality Reviews, Management Performance Reviews and Tier meetings.
• Define key performance indicators (KPIs) and metrics to monitor compliance with quality governance standards, collaborating with stakeholders to enhance quality systems and mitigate risks.
• Expand oversight using predictive analytics and advanced monitoring capabilities to increase transparency of identified quality risks.
• Develop innovative strategies to align QMS Processes with industry best practices.
• Partner with key stakeholders to identify potential risk areas and remediate systemic issues.
• Transform the governance and oversight strategy to provide proactive and timely mitigation of regulatory and quality risks via key forums.
• Notify relevant senior management and governance bodies of emerging and significant risks as appropriate.

Required Minimum Education: A minimum of a Bachelor’s Degree in engineering, science, or business is required. An advanced degree (MS) or MBA is preferred

Required Years of Related Experience:

• A minimum of 15 years of related experience in Quality management in a health care industry or in operations
• A minimum of 5 years of demonstrated people leader experience

Required Knowledge, Skills and Abilities:

• Strong understanding of GxP requirements
• Demonstrated ability to turn vision into strategies and a successful track record of gaining support to implement those strategies
• Leadership experience and skills:
• Strong personal leadership with demonstrated competency interfacing with senior leaders
• Strong networking and relationship building skills
• Experience working and leading within a global environment
• A proven track record of leading and developing people
• Strong organizational and people change leadership and management skills in a matrixed organizational set-up
• Ability to create an open and inviting environment
• Ability to embrace generational differences
• Proven business acumen
• Strong understanding of the digital and data science landscape
• Exceptional written and verbal communications skills
• Lean/six Sigma Certification or project management experience preferred
• Ability to travel up to 25%

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.