Executive Director, Corporate Quality

Biogen•Cambridge, MA

3d•Hybrid

About The Position

The Executive Director, Corporate Quality leads the creation and management of Biogen’s Global Quality Management System (QMS). The role oversees Quality Systems; internal and external cGMP audits, including audits of vendors and contract manufacturing organizations; IT Quality; Technical Product Complaints; and Central Knowledge Management, including documentation. It supports Quality and PO&T by managing risk and compliance performance, responding to regulatory changes, and identifying opportunities to improve the efficiency and effectiveness of PO&T’s cGMP systems. The role prepares semi-annual executive-level updates on the state of the QMS and informs Executive Management of potential business risks related to regulatory changes or systemic issues. It is also the principal liaison with R&D Clinical Compliance and provides guidance on ICH conformance. Oversight spans biologic products, ASOs, small molecules, gene therapy, devices, digital products, and combination products. The role is hybrid and based in RTP or Cambridge, with 25%–50% travel depending on location; more travel is required if not based in RTP. It leads integrated quality systems, policies, and standards across Biogen’s U.S. and international manufacturing sites and PO&T locations. The Executive Director oversees risk assessment, inspection response assessment, compliance metrics, regulatory monitoring, audit programs, computerized GxP systems, document and records lifecycle management, PO&T training standards, and complaint management. The role chairs the Global Management Review, establishes organizational goals and strategies, drives projects and programs within schedule and budget, manages multiple cost centers, interacts with regulatory agency representatives, and leads direct reports and managers of managers.

Requirements

Bachelor’s degree in a related field.
At least 15 years of leadership experience in the pharmaceutical industry.
At least 10 years leading a Quality Assurance, Regulatory, or Corporate organization at Director level or above in a highly regulated environment.
Experience with the FDA and EMEA, and preferably multiple additional regulatory agencies in other countries.
Quality and Compliance experience consistent with worldwide regulatory requirements.
Expert knowledge of U.S. and international cGxPs, ISO, ICH, and device regulations.
Excellent knowledge of the pharmaceutical product development process, ICH, and device regulations.
Ability to influence an organization through consistent execution of leadership competencies.
Strong leadership abilities to manage highly capable and high-performing teams.
Demonstrated ability to lead and implement change, with excellent communication and change management skills.
Ability to hire and retain top talent and a track record of developing leaders.

Nice To Haves

Experience with clinical and commercial products, large and small molecule programs, devices, and combination products.
ASQ or other auditing certification.
Advanced degree, such as a PharmD or PhD.

Responsibilities

Implement integrated quality systems, policies, and standards across 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 cGXP systems.
Ensure regulatory inspection responses are assessed holistically.
Establish goals and metrics that provide insight into industry benchmarks and trends relating to cGMP compliance.
Oversee monitoring of domestic and international regulatory updates and incorporate changes into Biogen’s QMS as needed.
Oversee internal and external GxP and ISO audit programs, including risk management and audit program oversight.
Ensure internal manufacturing sites, Quality Systems, and vendors operate in cGMP compliance, and communicate and escalate risks appropriately.
Oversee GxP IT computerized systems and underlying infrastructure; define standards and manage lifecycle documentation and supporting processes through system retirement.
Oversee GxP process and compliance-related content in the electronic document management system, including policies and process documents.
Protect, index, classify, and archive GxP records; digitally preserve vital records; manage records lifecycle; and translate GMP content as needed.
Oversee the PO&T training program and provide global guidance and standards for GxP training.
Develop and maintain policies and procedures for managing technical product complaints in line with industry and regulatory standards.
Direct complaint investigations, root cause analysis, CAPAs, regulatory responses, and launch readiness for new products.
Ensure complaint cases and metrics are trended and reported, with appropriate escalation and response to significant events.
Chair the Global Management Review to support 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 Global Management Review outcomes.
Establish short- and long-term goals, objectives, and strategies for the Global Corporate Quality organization.
Ensure policies and procedures measure, monitor, and report actual versus planned results.
Drive major organizational-unit or functional projects and programs to completion within schedule and budget.
Manage multiple cost centers and determine the organization’s overall objectives and long-range goals.
Interact directly with senior representatives of regulatory agencies, including the FDA and EMEA.
Manage direct reports and managers of managers to improve their performance and effectiveness.
Hire and retain top talent and develop leaders.
Lead and implement organizational change, communicating effectively and applying change management skills.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term cash bonus and equity incentive opportunities for eligible regular employees.