Associate Director, Quality Control Athlone
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Job Summary
About This Role:
As the Associate Director of Quality Control 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 Youll 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:
Bachelors 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 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.
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 onto learn more about our DE&I efforts.
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.
Required Experience:
Director
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
