Janssen Scientific Affairs, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Compliance and Quality Management. The position will be based in Titusville, NJ.
Janssen Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Associate Director, Compliance and Quality Management will:
• Develop and maintain primary monitoring and control systems, related tools, processes, and procedures, including the management of internal metrics, and management and oversight of the Janssen Scientific Affairs (JSA) CAPA system.
• Be responsible for facilitating awareness of regulatory and company compliance regulations, establishing a state of on-going Inspection and Audit Readiness, providing support for internal /external audits and inspections, and providing oversight of Corrections, Corrective and Preventive Actions (CAPAs) following audits and inspections.
• Identifies and provides knowledge of quality systems to minimize compliance risks while balancing business needs.
• Oversees and guides the JSA CAPA Champion Network within JSA business functions, including onboarding to the Trackwise Quality Management system and knowledge transfer of tools to manage nonconformances; trains JSA staff on methods for conducting root cause investigations as well as best documentation practices for CAPA.
• Monitors, supports, and maintains the JSA quality issue management/CAPA program by coordinating and overseeing processing of quality issues and non-conformances.
• Ensures appropriate documentation records in the Trackwise system.
• Responsible for initial quality approval of records in Trackwise as well as monitoring for completion of root cause investigations, CAPA implementation, closure and effectiveness checks.
• Serves as the Chair of the JSA monthly CAPA Review Board, facilitating quality issues and CAPA oversight, timely completion of quality records, proactive escalation of records in jeopardy of missing closure milestones and identification of resource issues. Provides routine status reports, and real-time ongoing communication with Head of C&QM on the state of active quality records and compliance to enterprise standards and timelines.
• Develops, monitors, and reports on internal compliance metrics, ensuring appropriate management oversight and escalation of compliance risks per company standards and /or in support of Management Review.
• Facilitates an awareness of regulatory and company compliance requirements within JSA.
• Facilitates and oversees the JSA state of on-going readiness for internal and/or external audits and Health Authority Inspections. Establishes processes, tools, training and infrastructure for Inspection Readiness.
• Leads/coordinates the logistical and administrative support for internal/external audits and Health Authority Inspections including management of pre-Audit requests and Audit Sharepoint documentation.
• Prepares Key Contacts, Subject Matter Experts (SME) as well as support personnel for audit readiness and oversees the staffing for the back room according to JSA internal procedures.
• Directs the back room during audits and ensures prompt response to requested information during the audit conduct.
• A minimum of a Bachelor's Degree in Engineering, Life Science, Management, or related discipline is required.
• An advanced degree (MS, MBA, PharmD, PhD, etc.) is preferred.
• A minimum of 5 years of experience working in a Quality or Compliance role within the Pharmaceutical, Consumer or Medical Device regulated industries is required.
• Working knowledge of 21 CFR Part 211 and 312 requirements is required.
• Knowledge of evolving Combination Products requirements is preferred.
• Experience supporting Health Authority Inspections such as FDA or MHRA is preferred.
• Direct experience with vendor/supplier audits is required.
• The ability to work autonomously on specific compliance or quality systems projects with accelerated timelines and ensure continuity of base business activities is preferred.
• The ability to think critically and be detail-oriented while overseeing multiple tasks for several projects is required.
• Experience identifying and investigating quality issues and leading in the development and implementation of corrective and preventive actions to address the identified root cause is required.
• Certification as a CAPA Lead Investigator, Process Excellence Green Belt or Black Belt is preferred.
• Strong written and verbal communication skills, the ability to perform as a change agent in a matrixed environment, and the ability to compile and present compliance data to management is required.
• Experience influencing remediation actions without direct authority is preferred.
• Experience documenting and approving quality issues in the Trackwise system is required.
• Experience with Documentum-based systems (retrieval of procedural documents) and a strong proficiency in MS Office suite of products is preferred.
• This position is located in Titusville, NJ and may require up to 10% local NJ/PA travel.
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J2W: LI NA
United States-New Jersey-Titusville
Janssen Scientific Affairs, LLC (6120)
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