Global Head of Biologics Quality & Compliance

Biogen, Inc.; Cambridge (MA); Hybrid; USD 184,000 - 253,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation and holidays

401(k) match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This hybrid role can be based at the Research Triangle Park, NC or Cambridge, MA, and involves strategic, tactical, and operational leadership within GMP-aligned processes.

The role requires extensive QA leadership, regulatory submission oversight, and cross-functional collaboration with CMC teams to drive quality excellence and continuous improvement.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Regulatory knowledge

GMP/GDP/ICH

Biologics development

Cross-functional collaboration

Communication skills

Negotiation skills

Matrix environment experience

Strategic planning

Regulatory submissions

Education

Bachelor’s degree in a relevant field

Tools

Quality systems management

CMC collaboration tools

Job description

Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This hybrid role can be based at the Research Triangle Park, NC or Cambridge, MA, and involves strategic, tactical, and operational leadership within GMP-aligned processes.

The role requires extensive QA leadership, regulatory submission oversight, and cross-functional collaboration with CMC teams to drive quality excellence and continuous improvement.