Head of Global Product Quality – Biologics

• Lead asset strategy and compliance best practices across products within a modality.
• Review major regulatory submissions and help set up regulatory strategic plans.
• Develop and cross-train staff for maximum flexibility and growth.
• Execute specification strategy for regulatory submissions and address agency concerns.
• Collaborate with cross-functional teams to support product specifications and shelf-life strategy.
• Serve as the Specification Review Board Chair and ensure cross-functional vetting of specifications.
• Represent Biogen at external forums to stay abreast of emerging expectations and trends.
• Ensure timely completion of Annual Product Review/Product Quality Review and trend monitoring.
• Support internal audits, certifications, and external audits of CMOs.
• Support combination product and device implementations in asset strategy.

• Bachelor’s degree and at least 12 years of experience in the pharmaceutical industry, with biological product development and/or production.
• At least 7 years of experience in Quality associated with biopharmaceutical/pharmaceutical production.
• Minimum of 5 years of experience in people management and project management.
• Extensive knowledge in GMPs, GCP, GDP, ICH, and international regulations.
• Experience in an international matrix environment.
• Technical expertise in manufacturing, testing, or technical development.
• Strong written and verbal communication skills.
• Ability to influence partners and stakeholders with strong negotiation skills.

Demonstrates extensive expertise in regulatory strategy and compliance within the pharmaceutical industry, with a strong focus on GMPs, GCP, and international regulations. Proven ability to lead cross-functional teams, manage projects, and influence stakeholders effectively.

• Regulatory Strategy Development
• GMP Knowledge
• Quality Management Experience
• People Management
• Project Management

• Regulatory Submissions
• Specification Strategy
• Biological Product Development
• Technical Development
• Trend Monitoring

• Strong Communication Skills
• Negotiation Skills
• Influencing Skills

• Pharmaceutical Industry
• Biopharmaceutical Production
• International Regulations
• GCP
• GDP
• ICH