About This Role: As the site Quality Compliance Lead, you will provide leadership and oversight of the site Quality Compliance program, ensuring the effective operation and continuous improvement of Quality Systems in accordance with applicable GxP requirements, company standards, and relevant regulatory requirements and guidance, including EU GMP Annex 1 for sterile manufacturing operations.
You will drive site inspection readiness through leadership of internal audits, regulatory inspection readiness and coordination, quality governance processes, and compliance monitoring activities, while providing Quality oversight of key systems including deviations, CAPA, change controls, quality risk management, validation governance, Annual Product Quality Reviews, and Management Review.
You will lead governance and oversight of the site Data Integrity and Data Governance programs, ensuring effective lifecycle management and compliance of GxP data.
Working cross-functionally, you will identify compliance risks, strengthen Quality Systems, and drive sustainable improvements that support a robust and effective Quality Management System. You will also serve as a key Quality representative during regulatory inspections, customer audits, and corporate compliance initiatives, helping to ensure the site maintains a consistent state of compliance and inspection readiness.
What You'll Do:- Lead site inspection readiness and Quality Compliance activities, including the self-inspection programme and regulatory inspection preparation and coordination.
- Host audits and regulatory inspections, and coordinate observation responses, commitments, action tracking and closure.
- Lead Quality Compliance governance of site Quality Systems, including cross-functional forums such as Deviation Review Board and CAPA Review Board, while maintaining clear functional ownership for investigation and process execution.
- Monitor Quality Management System effectiveness through metrics and compliance oversight, including the timely progression, closure and effectiveness of deviations, CAPAs and change controls, with appropriate escalation of compliance risks.
- Provide Quality oversight of Annex 1 compliance, working in partnership with cross functional owners to support effective implementation and ongoing compliance.
- Provide governance and oversight of site Quality Risk Management and Knowledge Management frameworks, ensuring consistent application of risk management principles and effective use of quality knowledge to support risk-based decision-making and continuous improvement.
- Lead Quality governance and oversight of the site Validation Program, ensuring an effective lifecycle approach and consistent application of validation requirements across GxP systems, facilities, utilities, equipment and processes.
- Provide Quality Compliance oversight of the preparation, review and approval of Annual Product Quality Reviews and Management Review outputs.
- Lead and develop the QA Compliance team, driving a culture of quality and continuous improvement.
- Benchmark standard operating practices across the internal network and external industry, leveraging best practices, emerging trends and shared learnings to drive continuous improvement and maintain effective, sustainable compliance.
- Communicate compliance risks, issues, and recommendations to site leadership.
Who You Are: You are a dedicated professional with a keen eye for detail and a passion for quality assurance. You excel in leadership roles, guiding teams with clarity and fostering a culture of accountability and continuous improvement. Your collaborative nature allows you to work seamlessly across functions, identifying compliance risks and implementing solutions. You possess a firm understanding of Quality Systems and regulatory requirements, ensuring the highest standards are met. Your analytical skills enable you to evaluate metrics effectively and drive meaningful change.
Required Skills:- Bachelor's degree in life sciences, engineering, pharmacy, or a directly related discipline.
- Experience in pharmaceutical or biotechnology manufacturing environments.
- Extensive experience in sterile manufacturing Quality Assurance, Quality Systems, and compliance.
- Demonstrated leadership in cross-functional Quality governance, investigation oversight, CAPA, change control and Quality Risk Management.
- People leadership or demonstrated leadership of Quality SMEs.
Preferred Skills:- Master's degree in a relevant discipline.
- Strong analytical skills with the ability to evaluate quality metrics and implement corrective actions.
- Excellent organizational, communication, and stakeholder management skills.
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.
