Clinical Compliance Business Operations Manager

le contenu du travail

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function

R&D Operations

Job Sub Function

Clinical Trial Project Management

Job Category

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, South Holland, Netherlands

Job Description

Integrated Data Analytics and Reporting (IDAR) comprises of: Data Management Central Monitoring, Clinical Data Standards and Transparency, Regulatory Medical Writing, Clinical & Statistical Programming,

Clinical & Portfolio Systems, And Business Operations. IDAR Is Part Of The Global Development Organization In The Johnson & Johnson Innovative Medicines Organization. IDAR Business Operations (IBO) Is Accountable For Establishing, Maintaining, And Continuously Optimizing Business Operational Activities, To Enable High Quality Deliverables (time, Cost, And Quality), With a Particular Focus On Leading Strategy & Operations For IDAR. This Is Accomplished By Utilizing a Broad Knowledge Of IDAR Functions, Drug Development, And Business Operations, Developing Highly Effective Cross-functional Relationships And Leveraging Data/insights To Enable Value Added Deliverables. Key Focus Areas Are

• Financial & Resource Management
• Business Management
• Operational Excellence
• Business Oversight of Vendors
• Central Services
  
  

In this position you will be responsible for compliance management under the Business Management pillar in IDAR Business Operations. This position will support all IDAR functions, and its Investigation Owners (IO) in the Corrective Action Preventive Action (CAPA) development and implementation process as a direct result of audits, health authority inspections and self-identified issues. You will oversee the Nonconformance/CAPA process and serve as the CAPA process expert for investigation owners through nonconformance identification, investigation, execution and resolution. Additionally, in this position you will be responsible for work distribution across the different CAPA managers and will provide input and support for various compliance related initiatives and projects.

Principal Responsibilities

• Act as CAPA Champion for any IDAR related Nonconformance.
• Act as process and system SME for the nonconformance and CAPA process and business/system requirements.
• Assist the Investigation Owner in the application of structured problem‐ solving methodologies in Root Cause Analysis (RCA) investigations (Fishbone, 5 Whys, etc.) independently or in support of the Root Cause Investigation team.
• Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process.
• Develop and maintain proficiency in the audit tracking system
• Work with the organization to identify resources to support RCA investigations and resulting actions.
• Provide assistance to the Investigation Owner to ensure process requirements are met.
• Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports, communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance.
• Act as a liaison between the IO and the quality leader; the IO and the Root Cause Analysis group; the IO and the Central Data Entry team.
• Escalate any issues, as needed, to the R&D Quality CAPA Review Board and attend the meetings if required.
• Raise any process or system questions or concerns to the Associate Director Business Operations - Compliance.
• Pro-actively plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner.
• Provide communications and training sessions to the IDAR organization on Compliance processes.
• Support and/or lead Compliance related initiatives or projects.
  
  

Education And Experience Requirements

• A minimum of a bachelor’s degree (University/college degree) in a scientific discipline or general management is required.
• A minimum of 4-6 years of GXP experience within clinical research and development and/or quality assurance is required.
• A minimum of 4-6 years of experience in diverse professional experience compassing program/project management, business operations in the pharmaceutical/biotech industry is required.
• Experience in Quality Control and Compliance, Quality Assurance, CAPA process and Root Cause Analysis is required.
• Well-developed skills and knowledge of business processes and practices (i.e., SOPs, etc.)
• Experience in quality assurance activities, including audits and inspections of regulatory submissions is preferred.
• Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment.
• Ability to motivate professional colleagues and stakeholders.
• Conflict resolution/management and negotiation skills.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
• Demonstrated project leadership skills.
• Up to 5% domestic travel is required