Senior Associate, GRADS Compliance Operations, Regulatory and Labeling (Remote)

Brief Description:

Under the leadership of the GRADS Compliance Operations, this role is responsible for the execution of issue management processes, assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve compliance, inspection readiness, and continuous improvement across the Regulatory and Labeling organizations.

Essential Functions/Responsibilities

• Responsible for all aspects of day-to-day issue management, communication, and escalation, CAPA resolution, documentation and timely communication to stakeholders and health authorities as appropriate.
• Manage and/or Advise on deviations and change control management process.
• Partner with Quality, Regulatory Affairs, Regulatory Operations and CMC and Labeling organizations in inspection readiness forums.
• Assist with all inspection management activities across Regulatory Affairs, Regulatory Operations and CMC and Labeling including developing readiness and execution plans such as training, storyboards, rehearsals, front and backroom support, notifications, logistic coordination, providing direction/coaching, schedules, ensuring appropriate subject matter experts are prepared, preparing for daily debriefs and close out meetings.
• Assist with post inspection activities including after action reviews, coordinating meeting and information, and ensuring timely responses.
• Collaborate with the GRADS Compliance Regulatory and Labeling Partner to ensure continuous improvement efforts are aligned and that the appropriate management reviews are established.
• In partnership with GRADS Compliance Regulatory and Labeling Partner, attend and participate in after-action reviews to learn and improve after any compliance incident.
• Collaborate with GRADS Compliance Process and Training to design a strategy to pre-empt compliance issues.
• Partner with GRADS Alliance Management to review metrics provided by GRADS Regulatory Affairs, Regulatory Operations and CMC and Labeling vendors for compliance concerns and opportunities.
• Participate in Vendor Governance meetings led by GRADS Alliance Management and attended by GRADS Compliance Regulatory and Labeling Partner.
• Partner with internal stakeholders to resolve any Regulatory and Labeling compliance or quality issues resulting from executed partnerships.
• Partner with GRADS Compliance Regulatory and Labeling Partner to lead in the compliance analysis in complex Regulatory Affairs, Regulatory Operations and CMC situations and provides recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.
• Act as an anchor to the commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality & compliance proactively.
• Engage with GRADS Compliance Regulatory and Labeling Partner in inspection efforts and developing responses to regulator questions as required.
• Act as internal investigator for the GRADS Compliance, reporting any discovered disparities and discrepancies to the Head of GRADS Compliance or delegate.
• Contribute to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as needed.

Required Knowledge, Skills, and Abilities

• 8 years R&D quality or compliance experience or relevant experience in Regulatory Affairs, Regulatory Operations, CMC and/or Labeling organizations.
• Proven ability to function autonomously in a matrix model and in a team environment.
• Travel Required: up to 30%
• Goes beyond the obvious and seeks novel approaches to complex issues.
• Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
• Works seamlessly with all levels of personnel and other R&D departments as well as quality, commercial, and manufacturing organizations.
• Driver of innovative and creative solutions for achieving GRADS goals and objectives in a high quality and cost-effective manner.
• Must be able to support highly complex multiple activities simultaneously.
• Must have proven track record to be able to think critically, strategically, independently and problem solve.
• Must have high level of motivation, drive, and demonstration of Jazz leadership values.
• Top notch interpersonal skills in difficult situations
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
• Excellent Microsoft office application skills as well as, e-mail and online meeting tool skills.

Required/Preferred Education and Licenses

• BS in Sciences (or equivalent); advanced degree preferred