Job Details

Overview

Brief Description: This role is responsible for providing strategic and operational leadership for global PV and REMS to execute the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement.

Responsibilities

• Provide overall GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, while ensuring data and scientific integrity practices are followed and consistent with global policies and procedures.
• Work collaboratively with GRADS Compliance Operations to support the build and optimization of the GRADS Compliance organization. Activities include providing management analysis and advice on situations (existing or future state) for PV and REMS organizations. Offer recommendations on quality reports, performance metrics, and act as a key advisor on methodologies and tools used to achieve continuous improvement.
• Sit on the extended leadership team of organizations supported to identify and mitigate risks, provide oversight to maintain a compliant state, monitor and influence key contributing metrics. Assist to improve and simplify processes (via BPO network) and introduce best practices for quality and compliance and identifies process gaps and facilitates resolutions congruent with industry best practices.
• Participate in GRADS Compliance Council and support business to report on KPIs and escalated topics
• Stay current with health authority actions and emerging regulations in global PV and REMS and share insights and advice with functional area leadership team and review impacts on compliance.
• Conduct after action reviews jointly with GRADS Compliance Operations with PV and REMS functional areas 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 Compliance Operations and GRADS Alliance Management to review metrics of vendors for compliance concerns and opportunities.
• Participate along with GRADS Compliance Operations in Vendor Governance meetings led by GRADS Alliance Management and provide the functional area compliance lens in assessing data presented.
• Participate in GRADS Alliance Management due diligence teams GRADS-wide Compliance as requested.
• Partner with key stakeholders to resolve any global compliance or quality issues resulting from executed partnerships.
• Partner with GRADS Compliance Operations to participate in the compliance analysis in complex situations and provides recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.
• Partner with PV and REMS to assist in the development of those area's business continuity plans and provide guidance and leadership with future testing and execution of BCP as needed.
• As a member of the GRADS Compliance Leadership team, responsible and accountable to make the quality and compliance of PV and REMS services such that these processes become enablers to the business and become a partner of choice.
• Apply business and management expertise to drive operational performance across the organization.
• Present complex processes, anticipate potential objections, and persuade others to adopt a different point of view if appropriate.
• Act as an anchor to the commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality & compliance proactively.
• In conjunction with global PV and REMS Leaders, foster compliance leadership across procedures and processes, employing compliance oversight with reference to regulations as required.
• Effectively engage Quality teams and support GRADS Compliance partner-aligned risk management strategies, plans, and processes.
• Support Compliance Operations in inspection efforts and developing responses to regulator questions as required.
• Responsible for PV and REMS knowledge transfer to GRADS Compliance and maintaining a current knowledge of industry compliance and quality trends.
• Contribute to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as needed.

Qualifications

• 8 years R&D quality or compliance experience or relevant experience in global PV or REMS
• 5 + years' experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
• Proven ability to function autonomously at a senior level 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.

Education and Licenses

• B.S. in Science (or equivalent) required and advanced degree preferred