Director, Global CAPA Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Horsham Pennsylvania United States of America Raritan New Jersey United States of America Titusville New Jersey United States of America

Job Description:

We are searching for the best talent for Director Global CAPA Management to join our Quality organization located in Raritan NJ; Titusville NJ; or Horsham PA.

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):

Belgium and Ireland - Requisition Number: R-090784

Switzerland - Requisition Number: R-090785

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Summary

• The Director Global CAPA Management serves as the Innovative Medicine (IM) Process Lead for NC/CAPA in support of the Global Process Owner (GPO) providing enterprise-wide leadership for the global NC/CAPA quality system. This role is responsible for maintaining improving and implementing standardized processes governance metrics and oversight mechanisms that enable effective identification mitigation and prevention of quality and compliance issues across IM. The Director works with the GPO to translate strategy into action plans and partners closely with senior leaders and cross-functional stakeholders to strengthen inspection readiness quality culture operational excellence and sustained compliance.
• This leader oversees a global team of quality professionals and drives continuous improvement of NC/CAPA procedures tools and system capabilities including the translation of evolving business and regulatory requirements into clear process and user requirements for digital platforms. The Director ensures robust process health assessment issue trending risk identification and governance review while enabling alignment across regions and functions. Through strategic leadership stakeholder engagement and change management this role advances a consistent data-driven and effective NC/CAPA framework that supports the IM quality management system.
  

Key Responsibilities

• Process Management & Continuous Improvement
  • Support the Global Process Owner in operating maintaining improving and remediating the NC/CAPA quality system framework. Manage and maintain global procedural documents tools and resources in support of the process.
  • Drive continuous improvement and remediation activities to ensure NC/CAPA processes remain aligned with business needs and evolving quality/compliance requirements. Lead projects or support strategic initiatives representing the requirements for the NC/CAPA process.
  • Drive implementation of one quality system. Support process Users with adequate training information tools and process improvements to enable optimized execution.
• Strategy Governance & Oversight
  • Establish and manage governance mechanisms including CAPA Review Board processes to ensure the health of the quality system NC/CAPA process enabling consistency and transparency into overall process effectiveness and compliance.
  • Lead independent monitoring of IM NC/CAPA process to identify trends and risks at an IM organizational level.
  • Monitor regulatory expectations and define business/user requirements for systems tools and reporting capabilities used to execute and oversee NC/CAPA processes.
• Partner with IM functions and senior stakeholders across Regulatory Compliance R&D Quality Supply Chain External Supplier Quality and Commercial Quality to ensure appropriate oversight engagement and awareness of compliance health.
• Support external and internal audit and inspection responses related to the NC/CAPA process in partnership with the Global Process Owner.
• Provide strategic leadership and coaching to direct reports to strengthen capability ensure alignment with standards and promote leading NC/CAPA practices.

Qualifications

• Education/Experience:
  • A minimum of a Bachelors degree is required.
  • At least 15 years of related experience in the pharmaceutical/medical device regulated industry is required and a minimum of 8 years of people management experience required.

• Knowledge skills:
  • Must be able to effectively work in a highly matrixed organization working across a global organization to drive alignment
  • High degree of interdependent partnering influencing and team work required.
  • Expert level of understanding of industry expectations for nonconformance root cause analysis corrective and preventive actions (end-to-end CAPA process) required.
  • Consistent track record of collaboration including the ability to work with global cross-functional teams and across complex matrixed negotiation and interpersonal skills to achieve and maintain alignment with stakeholder partners required.
  • Exceptional communications skills required verbally and in writing (including ability to translate complex concepts into clear communications ability to create executive messaging necessary for presenting to senior executives and ability to effectively listen and respond to inputs from broad base of stakeholders at all organizational levels).
  • Experience leading complex projects required.
  • Operates in a highly self-directed manner with minimal guidance to deliver strategic objectives. Uses appropriate project management tools to manage and track activities.
  • Ability to manage multiple projects and priorities to remain effective and focused on business critical objectives required.
  • Process Excellence and Project Management training/certification preferred. Project Management experience leading initiatives and teams is required.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & 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 external applicants please contact us via .Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Business Savvy Collaboration Compliance Management Consulting Corrective and Preventive Action (CAPA) Data Quality Developing Others Incident Management Inclusive Leadership Leadership Operations Management Performance Measurement Quality Control (QC) Quality Management Systems (QMS) Quality Services Quality Standards Risk Management System Integration Systems Analysis Tactical Planning

The anticipated base pay range for this position is :

$150000.00 - $258750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: Experience:

Director