Sr Manager, GSRS Quality-Audit and Inspection Readiness

Job Description

About This Role

As the Senior Manager, Audit and Inspection Readiness, you will partner with functional area experts within the SABR and GRA organizations to work as their quality resource to manage audit and inspection readiness activities.

Location: Baar, Switzerland working as per our Swiss HR hybrid working policy

What You’ll Do

• Develop and continually improve processes to prepare for and manage internal audits and health authority inspections of all Biogen Affiliates, Global Safety and Regulatory Affairs functions.
• Manage the global audit and inspection readiness program for Global Safety and Regulatory functions, including but not limited to:
  • evaluating processes for compliance to regulations
  • leading process improvements
  • preparing SMEs to present their functions during audits/inspections.
• Take a leadership role in managing internal audits and inspections, including hosting or strategy/control room activities.
• Evaluate proposed commitments to audit and inspection findings to ensure timely response and appropriate mitigation.
• Monitor commitments from audit and regulatory inspection findings to ensure accurate and timely completion.
• Provide regular reports to leadership on the status of audit/inspection readiness and commitments.

Who You Are

We are looking for someone who is passionate about Quality, loves to learn, and enjoys collaborating with many different functions.

Qualifications

Required Knowledge and Skills

• Bachelor’s or higher in life science (Biology, Health Sciences…), or bachelor’s or higher in nursing (BSN, BScN)
• Minimum 5 years’ experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and experience working in a quality or quality systems department
• Excellent communication skills (oral and written).
• Experience in pharmacovigilance and in the field of PV or clinical inspections.
• Excellent organizational and planning capabilities
• Ability to interact with inspectorates from Health Authorities in a constructive manner.
• Ability to establish effective business relationships with external stakeholders, including implementing process change.

Additional Information

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 our DE&I efforts.