This is a leadership position that will be customer facing and act as a strategic business partner that will work cross-functionally within the research organization (regulated and non-regulated) to ensure that an appropriate quality system is developed, implemented, maintained, and monitored to drive quality and compliance for the activities performed within each functional area. This position will also provide strategic advice and guidance for GLP, GCP, and non-GLP quality and compliance related matters.
1. Lead the Research Quality Operations team to ensure quality and compliance for all laboratory related study activities from research through clinical development. Allocate resources to each area and establish key objectives and metrics.
2. Act as a customer facing strategic business partner for the Research organization by providing regulated (GLP/GCP) and non-regulated laboratory quality and compliance expertise and guidance.
3. Develop an annual strategic quality plan for Research and partner with Research to drive the implementation of identified initiatives.
4. Support the evaluation, development, implementation, maintenance, and monitoring of fit-for-purpose quality systems and governance for the regulated and non-regulated areas within the research organization to ensure quality and compliance is built into the processes.
5. Provide quality and compliance advice and guidance to the GLP/GCP regulated areas of Research (Bioanalytical Development and Nonclinical Toxicology) and support those that sit in Development (Nonclinical PK/PD, and Clinical Pharmacology).
6. Analyze issues and identify risks to provide the Research organization with advice and guidance through risk-managed solutions.
7. Support Research with CAPA identification and investigation, development, and implementation. Ensure timely completion and closure of CAPAs through tracking and oversight.
8. Facilitate the assessment and investigation of quality issues. Provide expertise and recommendations. Ensure timely review and closure of quality issues through tracking and oversight.
9. Participate as a member of the R&D Quality and Compliance Leadership team (RDQLT) as well as other key Quality and cross functional committees/teams to ensure continuous alignment and proactive approach to GLP/GCP laboratory and preclinical compliance.
10. Provide quality input to core Research documents and SOPs. Review Research SOPs to assure compliance with the regulations, internal policies and standards, and procedures.
11. Ensure the regulated areas of Research are in a constant state of inspection readiness through robust process development and continuous improvement initiatives. Support inspection readiness activities as well as support any ongoing health authority inspections.
12. Act as the GLP Archivist and primary person responsible for the oversight and management of the Alexion GLP Archives
13. Participate in audits as an SME, as needed
14. Review audit reports of GxP Research vendors to detect trends of noncompliance issues both internally and externally
15. Identify and/or facilitate identification, evaluation, control, reporting, and monitoring of R&D quality risks
16. Participate on computer system validation teams as regulatory compliance lead
17. Develop Quality Agreements for critical GxP Research vendors and oversee the implementation and governance of the agreements