Executive Director, Corporate Quality

Biogen•Cambridge, MA

4d•$281,000 - $397,250•Hybrid

About The Position

The Executive Director, Corporate Quality is responsible for creating and managing Biogen’s Global Quality Management System (QMS). The role focuses on Quality Systems; internal and external cGMP audits, including audits of external vendors and CMOs; IT Quality; Technical Product Complaints; and Central Knowledge Management, including documentation. It manages quality risk and compliance performance, monitors regulatory changes, and seeks efficiencies in administering PO&T’s cGMP systems. The position informs Executive Management of QMS status, potential business risks from regulatory changes, and systemic company issues, and serves as the principal liaison with R&D Clinical Compliance while providing guidance for ICH conformance. Oversight spans biologics, ASOs, small molecules, gene therapy, devices, digital products, and combination products. The position is hybrid and based in RTP or Cambridge, with travel requirements of 25%–50%; more travel is required if not located in RTP. It implements integrated quality systems, policies, and standards across Biogen U.S. and international manufacturing sites and PO&T locations, including Baar, Cambridge, the Netherlands, Solothurn, and RTP. The role oversees risk assessment and regulatory inspection responses; internal and external GxP and ISO audit programs; GxP computerized systems and infrastructure; documentation and records lifecycle management; PO&T training; and complaint policies, investigations, trending, and escalation. As chair of the Global Management Review, the Executive Director ensures ongoing management review and awareness of Biogen’s quality and compliance performance and prepares semi-annual executive-level QMS updates. The role sets organizational goals and strategies, manages multiple cost centers, leads major projects and programs to schedule and budget, interacts with senior regulatory agency representatives including the FDA and EMEA, and manages direct reports and managers of managers. The role is intended for a seasoned pharmaceutical-industry leader with expert knowledge of U.S. and international regulatory requirements, strong leadership and change-management skills, and comprehensive knowledge of pharmaceutical product development.

Requirements

Bachelor’s degree in a related field.
At least 15 years of pharmaceutical-industry leadership experience.
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 with 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 hire and retain top talent, with a track record of developing leaders.
Strong leadership abilities and experience managing highly capable, high-performing teams.
Ability to influence an organization through consistent execution of leadership competencies.
Demonstrated ability to lead and implement change, with excellent communication and change-management skills.

Nice To Haves

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

Responsibilities

Create and manage Biogen’s Global Quality Management System (QMS).
Implement integrated quality systems, policies, and standards across Biogen U.S. and international manufacturing sites and PO&T locations.
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 related to cGMP compliance.
Monitor domestic and international regulatory updates and incorporate changes into the QMS as needed.
Oversee internal and external GxP and ISO audit programs, including risk management and audit-program oversight.
Ensure manufacturing sites, Quality Systems, and vendors operate in a state of cGMP compliance, and communicate and escalate risks appropriately.
Oversee GxP IT computerized systems across Biogen, including underlying infrastructure; define standards and manage lifecycle documentation and supporting processes through retirement.
Oversee GxP process and compliance-related content in the electronic document management system, including governing 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 appropriate 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 case and metric trending and reporting, with appropriate escalation and response to significant events.
Chair the Global Management Review (GMR), ensuring ongoing 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 policies and procedures measure, monitor, and report actual versus planned results.
Drive major organizational or functional projects and programs to completion within schedule and budget.
Manage multiple cost centers and determine organizational 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.
Serve as the principal liaison with R&D Clinical Compliance and provide guidance for ICH conformance.

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 additional 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 up to $10,000 per calendar year.
Employee Resource Groups participation.
Eligible regular employees may receive short- and long-term incentives, including cash bonuses and equity incentive opportunities.