Executive Director, Corporate Quality

About This Role:

The Head of Corporate Quality is responsible for creating and managing the Global Biogen Quality Management System (QMS). The main areas of focus include Quality Systems, internal and external audits for cGMP compliance (including external vendors and CMOs), IT Quality, Technical Product Complaints, and Central Knowledge Management (including documentation).

This role is central to Quality and PO&T, managing risk, compliance performance, staying compliant with regulatory changes, and seeking opportunities to gain efficiency and effectiveness in the administration of PO&T’s cGMP systems. Additionally, the role is accountable for preparing semi-annual executive-level updates on the state of Biogen’s QMS and informing Executive Management of potential business risks due to a changing regulatory environment or systemic issues within the company. This role also serves as the principal liaison with the R&D Clinical Compliance organization and provides guidance for ICH conformance. Oversight includes biologic products, ASOs, small molecule products, gene therapy, devices, digital, and combination products.

This role is hybrid- RTP or hybrid- Cambridge based.

Travel requirements: 25% – 50% depending on location. More travel required if not located in RTP.

What You’ll Do:

• Implement integrated quality systems, policies, and standards applicable to all Biogen U.S. and international manufacturing sites and PO&T locations, including Baar, Cambridge, Netherlands, Solothurn, and RTP.
• Develop and maintain a risk assessment process for evaluating and monitoring all cGXP systems.
• Ensure regulatory inspection responses are assessed holistically.
• Establish clear goals and effective metrics that provide insight into industry benchmarks and applicable trends regarding cGMP compliance.
• Oversee external monitoring of regulatory updates (domestic and international) and incorporate changes into Biogen’s QMS as needed.

• Internal and external GxP and ISO audit programs, including risk management and audit program oversight.
• Ensure Biogen’s internal manufacturing sites, Quality Systems, and vendors operate in a state of cGMP compliance, with any risks appropriately communicated and escalated.

IT QA Department:

• Oversee GxP IT computerized systems across Biogen, including underlying infrastructure.
• Define appropriate standards and manage lifecycle documentation and supporting processes to ensure compliant implementation and management through retirement.

Lifecycle Management:

• Oversee process and compliance-related content (specifically documentation, including governing policies, process documents, and other similar GxP documents) in the electronic document management system.
• Protect, index, classify, and archive GXP records, digitally preserve vital records, manage records lifecycle, and translate GMP content needed in multiple languages.
• Oversee the PO&T training program, providing global guidance and standards to ensure appropriate GxP training is conducted.

Technical Product Complaint Department:

• Develop and maintain policies and procedures to manage complaints in line with industry and regulatory standards.
• Identify strategy and provide direction to team members regarding complaint investigation, root cause analysis, CAPAs, regulatory responses, and launch readiness for new products.
• Ensure trending and reporting of complaint cases and metrics, including appropriate escalation and response to significant events.

Global Management Review (GMR):

• Act as the chair for the GMR, ensuring ongoing management review and awareness of Biogen Quality and compliance performance (in accordance with cGMP and ICH expectations).
• Prepare semi-annual executive-level updates on the state of Biogen’s QMS based on GMR outcomes.

• Establish short and long-term goals, objectives, and strategies for the Global Corporate Quality organization.
• Ensure appropriate policies and procedures are in place to measure, monitor, and report "actual" versus "planned" results.
• Drive major projects and programs for the Organizational Unit or Function to completion within schedule and budget.
• Manage multiple cost centers and determine the development of overall objectives and long-range goals of the organization.
• Interact directly with senior representatives of regulatory agencies, including the FDA and EMEA.
• Manage direct reports and managers of managers to increase their performance and effectiveness.

Who You Are:

You are a seasoned leader in the pharmaceutical industry with an expert understanding of both U.S. and international regulatory requirements. Your influence within an organization is felt through consistent execution and strong leadership competencies. With excellent communication and change management skills, you're adept at leading and implementing change. You thrive in a highly regulated environment and have comprehensive knowledge of the pharmaceutical product development process.

Qualifications

Required Skills:

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