Senior Director, Global Clinical Supply Compliance (Hybrid)

Job Description

Position Overview & Responsibilities

Are you passionate about serving patients with quality products? 

Within our Research & Development Division, the Global Clinical Supply (GCS) organization is accountable for the end-to-end supply chain (planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites and patients) across the product portfolio to enable the execution of Phase I-IV clinical trials in 60+ countries in accordance with worldwide GxP regulations as set by the US cFR, EU eudralex, and all applicable jurisdictions as well as Sarbanes-Oxley (SOX) financial, and Environmental Health & Safety agency guidelines. GCS operates in close collaboration with Discovery Sciences Clinical Supply (DSCS), Global Development Quality, our Research & Development Division Quality, GCS, Global Clinical Trial Operations (GCTO), Preclinical Development Sciences and Clinical Supply (PSCS), Procurement, Subject Matter Experts (SMEs), Translational Medicine, IT (COMET) and our Research & Development Division (including our Research & Development Division Quality Assurance/QA and our Research & Development Division's IT) to serve our company's patients.

The GCS Senior Director of Compliance is a key accountable leader on the GCS Operational Excellence Leadership Team (LT) and the overall GCS extended leadership team (XLT) with the following responsibilities (including but not limited to):

• Design and lead the strategy implementation and execution of the culture of compliance across GCS and provide support to West Point, WAG, Rahway, Haarlem and external network to deploy our company's Compliance strategic goals and objectives aligned closely with business objectives.

• Develop a system for GCS Compliance processes and quality system process ownership and assure that clinical supply chain processes are followed, executed, and maintained in a compliant fashion. 

  • Deviations

  • Corrective and preventive actions

  • Change controls

  • Audits and inspections

  • Documentation administration and control

  • Risk management

  • Environmental Health and Safety

  • Training including onboarding and upskilling

  • Complaint management and stock recoveries 

  • Compliance aspects of integrations, acquisitions, merged assets etc. 

• Accountable for success of audits and inspections and implementation of strategic responses that deliver results to action any potential areas for improvement identified in preparations or during audits and inspections, including on location support of Global audits and inspections.

• Develop and manage KPIs, assess trends, monitor, and lead monthly GCS Compliance forum as part of the Integrated Business Process to report output to stakeholders, driving improvement through targeted root cause analysis and action plans.

• Lead the Compliance Center of Excellence, which hosts Communities of Practice for Compliance areas of opportunity and upskilling, while developing …