Senior Manager, Global CAPA Management

Senior Manager, Global CapA Management

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Position Summary

• Ensures the implementation of standardized procedures, processes and systems for investigation of quality issues and corrective and preventive action (CAPA) across Innovative Medicines (IM) in compliance with all applicable Johnson & Johnson and external GxP regulatory requirements for drug, device and combination products
• Participates and leads global improvements to investigation and corrective and preventive action (CAPA) process and platform across Innovative Medicine (IM) sector, driving excellence in CAPA processes and execution.
• Responsible to ensure that user requirements and process needs are defined and translated into the QMS platform on behalf of the business and compliance needs of the process in partnership with Technical functions (IT and QMS platform owner). Engages with the system Platform Governance forum to ensure effective management of the NC/CAPA QMS.
• Supports the NC CAPA Global Process Owner (GPO) to establish and standardize CAPA processes at both sites and central functions, developing procedures, training and other tools and resources as necessary.

Key Responsibilities

• Global NC/CAPA Business Process liaison with Technical teams
• Provides Quality System oversight to NC/CAPA QMS development activities including QMS platform system modifications, data modifications to production records, system requirements/business input, business communications to Users/Stakeholders, release notes for system releases
• Assesses system defects for severity/business impact and ensures the technical project team understands the business priorities/compliance risks for system issues
• Is expert in NC/CAPA business process and compliance requirements and fluent in technology application to enable appropriate translation and guidance
• Performs Business Simulation Testing and User Acceptance Testing to ensure the development meets the business expectations and requirements
• Gives business context input to test team to ensure the testing reflects how the business uses the system
• Partners with Platform Owner to approve IT tickets to change/modify production records, troubleshoot workflow issues, liaise with software vendor to further investigate serious issues
• Continuous Improvement of NC/CAPA QMS platform
• Represents Global Process for NC/CAPA to give input to future design changes and enhancements
• Engages CAPA Subject Matter Experts (SME)/Coaches in the business to improve and align processes locally.
• Reviews the COMET Intake requests and works with the business to identify and prioritize implementation of the enhancement request items.
• Coordinates review and approval of master data elements owned by GPO.
• Assesses QMS platform design enhancements/strategies with the technical teams and vendor.
• Supports or leads key projects for NC/CAPA as required.
• Leadership and Change Management
• Has significant responsibility to engage with various levels of leadership on a global level and cross functionally to gain alignment and support for planned projects in relation to the standardization and improvement of CAPA processes across IM.
• Ensures the integration / linkage of CAPA processes with other elements of the Quality System (risk management, escalation of quality issues, change control etc.).
• Acts as SME resource for consultation: Assists Users with the development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination.
• Delivers education and interactive training for investigation and CAPA users to deliver consistent compliant records including Failure Investigation, CAPA Review Boards, and CAPA content.
• Supports internal and external audits of IM investigation and CAPA processes including development of appropriate responses and ownership of global actions to any related observations.
• Serves as a quality record approver and completes training activities as required.
• Ensure compliance with GxP and other business & regulatory requirements and guidelines.
• As needed, represents Quality Issue Management processes for NC/CAPA in IM segment and J&J Enterprise forums, councils and teams.

Qualifications

• Education/Experience:
• A minimum of a Bachelor's degree is required.
• At least 8 years of related experience in the pharmaceutical/medical device regulated industry is required.
• Project Management and Quality Systems Implementation 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.
• Strong collaboration and excellent communication skills verbally and in writing 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.