The posting
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:
- 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.
Preferred Skills:
- Advanced degree (PharmD, PhD)
#LI-NP1
Job Level: Management
Additional Information
The base compensation range for this role is: $281,000.00-$397,250.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
