This leader will:
- Be accountable for the development and implementation of a global strategy to plan, control, and improve quality for all aspects of Global Medical Affairs (GMA) activities.
- Serve as the lead for GMA compliance with global regulations for medical affairs activities for multiple products.
- Influence GMA senior executives to successfully embed a strong Quality governance model including a dashboard of key quality performance indicators (KQPIs) to oversee the performance of the GMA Quality Management System (QMS)
- Identify, evaluate, and drive the remediation of fundamental risks and issues within GMA to drive quality, in collaboration with GMA, in company's Development programs and post approval programs.
- Partner with Regional Quality representatives to assure understanding and application of global regulations in GMA activities.
- In partnership with the GMA Leadership team, create an annual strategic quality management plan (QMP) based on current risks that will govern and oversee the implementation of the QMS.
- Serve as Quality Operations Lead for global GMA-related quality issue investigations and CAPA management process, which includes:
- Leading investigations with GMA issue owners and perform root causes analyses
- Performing risk assessments on GMA issues and audit findings to determine the need for CAPAs
- Reviewing and approving CAPAs proposed by GMA
- Monitoring CAPA metrics and reporting quarterly to Senior level quality leadership and executive management
- Be accountable for the strategy and execution of inspection readiness for GMA, including SME training/preparation and back room support during inspections. Analyze the risks, propose the strategy for readiness and manage the implementation of the inspection readiness program.
- Collect and monitor compliance metrics globally and evaluate possible trends and partner with GMA to develop global CAPAs as needed.
- Identify key GMA risks and support the implementation of GMA quality risk mitigation plans where appropriate.
- Support development of risk-based audit strategies in partnership with GxP Audit.
- Review and serve as Quality Approver for GMA SOPs.
- Consult with Clinical Operations Quality Lead and GPV Quality Lead to ensure GCP/GVP compliance in GMA.
- Develop or review relevant GxP SOPs governing Quality activities as well as other functional area activities.
- Provide oversight for all quality issue management including audit reports, quality issues/incidents, and CAPA development.
- Ensure timely implementation and closure of CAPAs.
- Assure appropriate escalations and notification to executive level management is occurring for all GMA-related issues.
- Facilitate the assessment and investigation of quality issues, by driving root cause analysis and remediation. Provide expertise and recommendations.
- Ensure timely review and closure of quality issues.
- Serve as an internal expert in the management of GMA quality systems
- 10 or more years' experience in GMA and quality assurance in both tactical and strategic capacities
- Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
- Significant experience with PV investigations, risk assessments and CAPA management
- Experience participating in regulatory inspections
- Functional planning experience and ability to develop functional vision, priorities and tactics
- Experience with multinational products and regulations as well as with mandated risk management plans
- Bachelor’s degree in life science required. Advanced degree strongly preferred.
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.