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 and implementing processes and tools to ensure adherence to applicable company policies and quality management system (QMS) standards.

• Support the overall mission of the GCS Operational Excellence team to instill a continuous improvement culture collaborating with GCS management and staff, Research & Development Division Quality Assurance, Learning and Development, Clinical Quality and Improvement, Corporate Compliance and Supply Chain stakeholders globally.    

• Lead team of GCS Compliance Professionals and functional service providers including talent attraction, development, and retention, team performance management, motivation, and engagement aligned to a resource model that meets the needs of the customer base in GCS and DSCS with attention to diversity, equity, and inclusion.

Qualifications

Education & Experience:

• Bachelor's degree with 15 years of clinical supply experience or MBA and 12 years of clinical supply experience.

• 5+ years people management experience.

Skill-based Qualifications:

• Ability to develop a strategic plan that influences the collective organization to execution excellence for delivery on customer needs and perspectives be it stakeholders or patients

• Process Design for compliance and quality system implementation and maintenance that drives and embodies ownership and accountability

• Operate with an entrepreneurial mindset staying current on pharmaceutical industry compliance trends and tools via