Quality Control Lead (Sterile Product Manufacturing)

About This Role:

As the Quality Control Lead at our Athlone site, you will be a pivotal leader in ensuring the integrity and compliance of our Quality Control operations. This role is crucial for establishing and maintaining site-wide QC processes in alignment with EU GMP, FDA, and global regulatory standards. You will oversee incoming inspection, raw material, in-process, environmental monitoring (EM), utility testing, and finished product testing and release, including governance of the site EM program. The role focuses on enabling site start-up, ensuring sustained GMP compliance, and maintaining a continuous state of inspection readiness. Your leadership will extend to laboratories, personnel, equipment, analytical methods, and systems, guaranteeing they are aptly designed, validated, and maintained for use in line with regulatory expectations. By proactively shaping future QC capability and advancing technology and digital innovation, you will position the function to support evolving pipeline and manufacturing demands. Through strong cross-functional partnership, you will enable compliant QC operations, while leading the successful introduction of new programs and technologies that strengthen and future-proof the site in line with business needs.

This role requires working on site for 5 days per week in Athlone.

What You’ll Do:

• •Exercise full Quality Control authority and compliance oversight including approval or rejection of products and materials.
• •Lead the establishment and continuous improvement of site Quality Control laboratories.
• •Build, hire, and develop a high-performing QC organization.
• •Support procurement, installation, and qualification of laboratory equipment.
• •Participate in site Quality Management Review, providing oversight of QC performance.
• •Establish, implement, and maintain compliant QC systems and procedures.
• •Author, review, and approve complex GMP documentation.
• •Support analytical method transfer, validation, and lifecycle management.
• •Generate and assess current and future QC needs and manage associated department budget.
• •Maintain effective oversight of outsourced activities.
• •Partner cross-functionally to enable compliant product release and new technology introductions.

Who You Are:

You are an insightful leader, eager to steer Quality Control operations towards excellence. Your analytical mind allows you to navigate complex regulatory landscapes and implement effective systems. You thrive in dynamic environments, managing multiple priorities while fostering a culture of compliance and continuous improvement. Your collaborative spirit drives you to work cross-functionally, ensuring the seamless integration of new technologies and methodologies.

Required Skills:

• •Bachelor’s degree in Science or directly related discipline.
• •Strong experience within GMP compliant Quality Control or Analytical functions.
• •Significant experience in pharmaceutical or biotech analytical environment.
• •Strong experience of personnel and project management experience.
• •Experience with QC Microbiological Analysis, analytical method transfer and validation

Preferred Skills:

• •Start-up Experience
• •Complex Biologic Method Experience
• •Advanced degree in a related field.

Eligibility for Qualified Person (QP) is a distinct advantage.

Strong budget management and financial approval capabilities.

Job Level: Management

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.