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