Executive Director, Corporate Quality

Biogen

. Create and manage the Global Biogen Quality Management System (QMS) .

Posted 11/2/2026full-timeUnited StatesLead💰 $281,000 - $397,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in managing Quality Management Systems (QMS) and ensuring compliance with cGMP, ISO, and ICH regulations. Proven ability to lead teams, drive organizational change, and effectively communicate with regulatory agencies.

Highest-signal resume keywords

Quality Management System (QMS) ManagementCGMP Compliance LeadershipRegulatory Agency Interaction (FDA, EMEA)Risk Assessment and ManagementQuality Assurance and Compliance Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CGMP Systems ManagementRisk Assessment ProcessesRegulatory Inspection ResponseComplaint Management PoliciesRoot Cause AnalysisCAPA ImplementationQuality Systems IntegrationAudit Program OversightGxP Documentation ManagementPharmaceutical Product Development Knowledge

Soft Skills

Leadership AbilitiesChange Management SkillsCommunication SkillsTeam DevelopmentInfluencing Skills

Tools & Technologies

GxP IT Computerized SystemsQuality Management SoftwareAudit Management ToolsDocument Management SystemsTraining Management Systems

Certifications & Qualifications

ASQ CertificationAuditing Certification

Industry Keywords

Pharmaceutical IndustryBiotechRegulatory ComplianceICH GuidelinesISO StandardsClinical and Commercial ProductsDevice RegulationsCombination ProductsQuality AssuranceRegulatory Agencies

About the role

Key responsibilities & impact

Create and manage the Global Biogen Quality Management System (QMS)
Lead Quality Systems, internal and external audits for cGMP compliance, IT Quality, Technical Product Complaints, and Central Knowledge Management
Manage risk, compliance performance, regulatory changes, and efficiency of PO&T’s cGMP systems
Prepare semi-annual executive-level updates on the state of Biogen’s QMS and inform Executive Management of potential business risks
Serve as principal liaison with R&D Clinical Compliance and provide guidance for ICH conformance
Implement integrated quality systems, policies, and standards across Biogen U.S. and international manufacturing sites and PO&T locations
Develop and maintain risk assessment processes for cGXP systems
Ensure regulatory inspection responses are assessed holistically
Establish goals and metrics regarding cGMP compliance
Oversee regulatory updates and incorporate changes into Biogen’s QMS
Oversee internal and external GxP and ISO audit programs
Ensure manufacturing sites, Quality Systems, and vendors operate in cGMP compliance, with risks communicated and escalated
Oversee GxP IT computerized systems and infrastructure, standards, lifecycle documentation, and compliant implementation through retirement
Oversee GxP documentation, records protection, indexing, classification, archiving, digital preservation, records lifecycle management, and translation of GMP content
Oversee the PO&T training program and global GxP training standards
Develop complaint-management policies and procedures
Direct complaint investigations, root cause analysis, CAPAs, regulatory responses, and launch readiness
Ensure complaint trending, reporting, escalation, and response to significant events
Chair the Global Management Review and maintain awareness of Quality and compliance performance
Establish organizational goals, objectives, and strategies
Measure, monitor, and report actual versus planned results
Drive major projects and programs to completion within schedule and budget
Manage multiple cost centers and long-range organizational goals
Interact with senior representatives of regulatory agencies, including the FDA and EMEA
Manage direct reports and managers of managers to improve performance and effectiveness

Requirements

What you’ll need

Bachelor’s degree in a related field with a minimum of 15 years of leadership experience in the pharmaceutical industry
Minimum of 10 years’ experience leading a Quality Assurance, Regulatory, or Corporate organization at the Director+ level in a highly regulated environment, preferably in biotech, pharmaceutical, or similar industry
Experience with the FDA, EMEA, and preferably multiple additional regulatory agencies in other foreign countries
Experience in clinical and commercial products as well as both large and small molecule programs, device, and combination products is strongly preferred
ASQ or other auditing certification is beneficial
Quality and Compliance experience consistent with worldwide regulatory requirements
Expert knowledge of US and International cGxPs, ISO, ICH, and Device regulations
Ability to hire and retain top talent with a track record of developing leaders
Excellent knowledge of the pharmaceutical product development process, ICH, and device regulations
Ability to influence the organization through consistent execution of Biogen leadership competencies
Strong leadership abilities required to effectively manage highly capable and high-performing teams
Demonstrated ability to lead and implement change, including excellent communication and change management skills
Advanced degree (PharmD, PhD) preferred

Benefits

Comp & perks

Regular employees are eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities
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 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