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. Requirements 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. Core Competencies 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. Highest-signal resume keywords Regulatory Strategy Development GMP Knowledge Quality Management Experience People Management Project Management ATS Optimization Keywords Hard Skills Regulatory Submissions Specification Strategy Biological Product Development Technical Development Trend Monitoring Soft Skills Strong Communication Skills Negotiation Skills Influencing Skills Industry Keywords Pharmaceutical Industry Biopharmaceutical Production International Regulations GCP GDP ICH #J-18808-Ljbffr Jobtailor