Associate Director GRADS Compliance Partner, REMS and PV (Remote)

Jazz Pharmaceuticals, Inc.; New Addington; Remote; GBP 100,000 - 125,000; Full time

Job summary

A global biopharma company in the UK is seeking an experienced leader to provide strategic and operational direction for global PV and REMS compliance. The ideal candidate will have over 8 years of experience in R&D quality or compliance and 5+ years engaging with senior leaders. Join a dedicated team focused on developing life-changing medicines for serious diseases.

Qualifications

• 8 years of R&D quality or compliance experience.
• 5+ years working with senior leaders with proven accountability.
• Ability to function autonomously at a senior level.

Responsibilities

• Provide overall compliance support for PV and REMS processes.
• Work collaboratively with operations to optimize compliance.
• Participate in compliance council and report on KPIs.

Skills

R&D quality or compliance experience

Interpersonal skills

Communication skills

Negotiation skills

Problem-solving skills

Education

B.S. in Science or equivalent

Advanced degree preferred

Job 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.

Essential Functions/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.
• 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.
• 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.

Requirements:

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

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.

We are an equal opportunities employer and welcome applications from all qualified candidates.