Sr. Manager, Quality Risk Management - R&D Compliance

This role will provide expertise and guidance related to relevant and current GxP (GCP, GLP, GVP) regulations and guidelines as well as those non-GxP compliance guidelines that impact R&D functions enabling transparency and escalation of R&D quality and compliance issues. It is expected that this role provide expertise in the following areas:

• CAPA prioritization, development and execution as pertains to major and critical audit or inspection findings and quality issues requiring CAPA
• Develop and evaluate relevant metrics
• Proactively assess potential risks and recommend mitigations/remediations to relevant R&D staff
• Understanding when and providing guidance on how to escalate quality issues and acts as point of escalation of identified risks to governance boards and senior leadership
• Risk evaluation and consultation on quality and compliance issues
• Lead inspection readiness and inspection management activities


Key Responsibilities:
1. Provides strategic direction and advisement to functional quality representatives (FQRs) and Process Owner Network (PON) to support ongoing implementation and maintenance of R&D QMS
2. Provides instruction and consultation on the use of risk assessment and process improvement methodologies
3. May serve as the GxP inspection lead providing strategic guidance and or/oversight of planning, conduct, close-out of inspections as well as post-inspection responses.
4. Serves as key cross functional decision maker regarding compliance/quality risk management/ mitigation prioritization associated with regulatory inspection planning and execution
5. Drives execution of R&D GxP quality and/or compliance initiatives that have cross-functional R&D impact or as it relates to a critical compliance issues.
6. Provide support, leadership, coordination, direction, advisement and/or oversight in the implementation of new and existing GxP requirements in R&D.
7. Support and/or lead GCP serious breach assessments.
8. Supports process owners in designing and implementing relevant RDQC processes and procedures including metrics, thresholds, and continuous improvement initiatives
9. Serves as ad hoc Chair for Quality Council (QC) and as such determines agenda items for discussion and escalation to Quality and Compliance Executive Committee (QCEC) Chair.
10. Serves as coordinator for QCEC meetings
11. Provides direction and leadership to direct reports and mentorship to more junior level staff in RDQC.

#LI-ML1

• Experience in pharmaceutical or biotechnology drug development
• Several years in a quality or compliance related discipline or equivalent quality management activities
• Basic knowledge of international GxP drug development regulations, including USA

The Sr. Manager, Quality Risk Management - R&D Compliance supports and/or leads R&D Quality Risk Management (QRM) initiatives and serves as a Research & Development Quality and Compliance (RDQC) resource for compliance or quality issues that impact R&D functions. This includes partnering with Quality and Compliance organizations across R&D and throughout the Biogen organization.