Senior Director, GCS Inspection & Risk Management Lead

Role Summary

The Senior Director, GCS Inspection & Risk Management Lead is responsible for shaping quality culture and leading GCS Quality Management activities across the Global Clinical Supply organization. They provide strategic leadership for quality governance, inspections, audits, and risk management, and oversee quality records, metrics, and inspection readiness. The role develops talent within Quality Investigation Leads and Inspection Readiness Leads, ensures SOP compliance, and drives cross-functional process improvements.

They collaborate with stakeholders across GCS and corporate partners to resolve issues and sustain enterprise-level quality programs.

• Lead and oversee the Inspection Readiness and Quality Investigation functions in IRM, including line management of GCS Quality Investigation Leads (QILs) and GCS Inspection Readiness Leads (IRLs), and matrix management of GSH Quality Management Specialists.
• Develop and retain talent through targeted career development, performance management, and an inclusive culture; lead hiring, selection and training of new hires and create Training Plans for IR Leads and QI Leads.
• Serve as the main point of contact for all GCS quality records; coordinate with GCS functional lines, PSOQ and CD&O to ensure timely processing and closure of records; support procedural updates; determine documentation strategy for quality issues; monitor workload and support Quality Investigation Leads.
• Lead audits and inspections activities: main point of contact for all GCS related audits and inspections; oversee compliance with PTMF requirements; monitor metrics; ensure timely readiness and processing of findings; liaise with RQA, Corporate Audit, GCSO, and other functions to prepare for and respond to inspections.
• Represent GCS in Quality Management Review Boards; drive quality culture; share best practices; develop partnerships across functions; lead trending and analysis of quality data; drive digital and process innovation in tools and workflows (automation, analytics).
• Lead strategic initiatives as part of the IRM LT and GCS eLT to evolve IRM and GCS.

• Required:
  
  BA or BS; advanced degree in Life Sciences, Pharmacy, or related field
• Required:
  
  Minimum 15 years of pharmaceutical experience with strong experience in clinical supply chain and clinical studies, GMP/GCP quality, compliance, risk and issue management
• Required:
  
  Experience in Inspection/Audit readiness
• Required:
  
  Experience in quality investigation processes; management and direct supervision of internal resources; strong knowledge of GMP, GCP, SOPs and regulations
• Preferred:
  Advanced degree in Life Sciences
• Preferred:
  Thorough understanding of clinical supplies and clinical studies, and related planning and operational processes
• Preferred:
  Demonstrated experience in supporting continuous improvement projects
• Preferred:
  Strong leadership, influencing, negotiation, and management skills; breadth of diverse leadership experiences and capabilities

• Strong people management skills, including developing and coaching others
• Strong organizational and planning skills, with keen attention to detail
• Strong project management skills and ability to prioritize multiple and complex projects while meeting targeted deliverables and deadlines
• Strong analytical and problem-solving abilities
• Ability to work independently with limited guidance
• Ability to adapt to changing situations and work well under pressure
• Strong and effective verbal and written communication skills; uses a variety of tools to present complex ideas and influence others
• Excellent stakeholder management skills
• Ability to lead cross-functional initiatives and drive continuous improvement
• Proven ability to function autonomously in a matrix model and in a team environment
• Technical proficiency with MS Word, MS Excel, MS Project, Visio;
  Office
  365 and SharePoint;
  CoPilot; tools for analysis and graphing;
  Spotfire; and document management and learning management systems

• BA/BS required; advanced degree in Life Sciences, Pharmacy, or related field

• Travel will be minimal; may include domestic and international travel to GCS sites
• May require working across US, EU, and Asia hours to support global colleagues
• Hybrid work arrangement: onsite an average of 2.5 days per week