Director - Quality Operations Capabilities - Biogen Idec - Cambridge

Job description
This position provides overall strategy and leadership for the quality management system within Global Clinical Operation (GCO). The lead is responsible for developing the quality measures, analysis and reporting to support proactive quality management and for embedding a culture of quality within the organization. They provide information and knowledge regarding ICH/GCP, global regulations, and quality standards. They provide overall leadership and decisions for risk and risk mitigations managed within GCO. . They are the functional liaison for R&D Compliance’s quality and compliance program and lead GCO’s contributions to audit and inspection planning, management, and responses.

Principal Accountabilities:
1. Manages an experienced team, including hiring and performance management
2. Collaborates closely with R&D Compliance for communication, issue escalation, process development
3. Builds a sustainable platform for continuous process improvement based on stakeholder feedback, inspections, and audits. Helps define metrics and measures for quality to drive assessment and continuous improvement
4. Accountable for GCO contributions to audit plan, management, and responses
5. Accountable for GCO Inspection Readiness, management and responses
6. Define processes, tools, trainings, and job aids to support a Quality Management System within GCO
7. Regulatory and Quality intelligence: maintains up to date knowledge and guides impact to processes with appropriate process owners and senior leaders

Qualifications

1. Must have extensive clinical trial operational experience (10-15 years)
2. 7+ years in compliance or quality function or equivalent
3. In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives, as examples)
4. Managerial experience is required
5. Excellent written and verbal communication skills
6. Must be able to manage change and lead a learning organization
7. Strong skills in influencing without direct authority required. Must be highly influential contributor.
8. Understanding of quality by design, risk assessments, quality measures, and metrics is critical
9. Judgment and decision making skills: makes sound decisions that incorporate stakeholder input. Engages appropriate stakeholders to build consensus. Ability to independently make decisions

Education

Bachelor’s Degree required. Master’s or Advanced Degree preferred

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