About This Role 
The Manager/Sr. Manager, Quality Process & Standards contributes to the strategy and implementation of quality oversight, best practices, and training within Global Clinical Operations (GCO). The primary responsibility is to provide Process and Standards leadership and support to relevant sub-functions within GCO. Secondarily, support Quality/Compliance through involvement in QMS quality by design activities.

What You’ll Do 

• Review and assess controlled documents for possible gaps with respect to quality, compliance, and regulatory requirements
• Participate in process improvements and functional and cross-functional initiatives
• Reviewing GCO process deviations and periodic reviews for compliance & completeness
• Evaluate risks and mitigation strategies and determine requirements for escalation and communication to functional/quality leadership
• Overseeing and approving CAPAs / Effectiveness checks

Who You Are 
You love process improvement and analytical thinking around ICH-GCO compliance. You have a keen interest in close collaboration within your function and across others. 

Qualifications

• Bachelor's Degree within life sciences
• 2 - 5 years for Manager and 5+ years’ experience for Sr Manager in clinical operations and / or compliance or quality function or equivalent
• In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives, as examples)
• Clinical trial systems and process proficiency.
• Excellent written/verbal communication skills: including facilitation (meeting/discussions)
• Ability to identify areas for process improvement & influence to implement change
• Ability to partner and influence functional area colleagues and SMEs
• Coachable mindset: receptive to feedback, receiving constructive criticism, & using feedback to improve performance
• Comprehensive decision-making skills

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. 

All your information will be kept confidential according to EEO guidelines.