Senior Manager, Global CAPA Management

Job Location(s): Horsham, Pennsylvania; Raritan, New Jersey; Titusville, New Jersey. 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 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 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, and release notes for system releases. Assesses system defects for severity/business impact and ensures the technical project team understands the business priorities and compliance risks for system issues. 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, giving business context input to the test team. Partners with platform owner to approve IT tickets to change or modify production records, troubleshoot workflow issues, and liaise with software vendor to further investigate serious issues. Continuous improvement of NC/CAPA QMS platform, representing the global process for NC/CAPA to provide input to future design changes and enhancements. Engages CAPA subject matter experts or coaches to improve and align processes locally, reviews the COMET intake requests, and works with the business to identify and prioritize implementation of enhancement request items. Coordinates review and approval of master data elements owned by the GPO, and assesses QMS platform design enhancements or strategies with 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 related to the standardization and improvement of CAPA processes across IM. Ensures integration of CAPA processes with other elements of the quality system, such as risk management, escalation of quality issues, and change control. Acts as SME resource for consultation, assisting users with the development of problem statements, containment and correction, root‑cause and action plan determinations, including effectiveness monitoring. Delivers education and interactive training to CAPA users, including failure investigation, CAPA review boards, and CAPA content. Supports internal and external audits of IM investigation and CAPA processes, developing appropriate responses and owning global actions to any related observations. Serves as a quality record approver and completes required training activities. Represents Quality Issue Management processes for NC/CAPA in IM segment and J&J enterprise forums, councils and teams, ensuring compliance with GxP and other business and regulatory requirements and guidelines. Qualifications Minimum of a bachelor’s degree. At least eight years of related experience in the pharmaceutical or medical device regulated industry. Project management and quality systems implementation experience required. Ability to work effectively in a highly matrixed organization, working across a global organization to drive alignment. High degree of interdependent partnering, influencing, and teamwork required. Expert-level understanding of industry expectations for nonconformance, root‑cause analysis, and corrective and preventive actions (end‑to‑end CAPA process). Strong collaboration and excellent verbal and written communication skills. 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. Process excellence and project management training or certification preferred. Required Skills Analytical reasoning Analytics dashboards Compliance management Data gathering and analysis Data quality Incident management Organizing Performance measurement Quality control (QC) Quality management systems (QMS) Quality services Quality standards Risk management Standard operating procedure (SOP) System integration Systems analysis Tactical planning Technical credibility Pay Transparency Anticipated base pay range: $122,000.00 - $212,750.00 Eligible for consolidated retirement plan (pension) and savings plan (401(k)). Vacation: 120 hours per calendar year. Sick time: 40 hours per calendar year (48 hours for employees residing in Colorado, 56 hours for employees residing in Washington). 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 or 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 period. Volunteer leave: 32 hours per calendar year. Military spouse time‑off: 80 hours per calendar year. Equal Opportunity Employer 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. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via #J-18808-Ljbffr