Head of Global Product Quality – Biologics

Biogen

Head of Global Product Quality at Biogen, managing product quality for biologics. Leading a dynamic team, ensuring compliance with policies and GMP guidelines.

Posted 7/23/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $184,000 - $253,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

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 DevelopmentGMP KnowledgeQuality Management ExperiencePeople ManagementProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsSpecification StrategyBiological Product DevelopmentTechnical DevelopmentTrend Monitoring

Soft Skills

Strong Communication SkillsNegotiation SkillsInfluencing Skills

Industry Keywords

Pharmaceutical IndustryBiopharmaceutical ProductionInternational RegulationsGCPGDPICH

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation