Rems Quality Operations Lead Jobs

Review and monitor regional risk management programs.

Author SOPs as needed/requested by PSRM management. Review existing SOPs and author updates as required.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and

Working with regulatory affairs to understand, interpret and agree on suitable CMC submission strategies for the life-cycle management of approved products.

Management and execution of sustainable performance improvements

Prepare and present project update reports to senior management as required

Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement

Previous experience working with FDA and participating in regulatory agency inspections

Extensive experience in quality, manufacturing or MS&T departments of a commercial pharmaceutical manufacturing company

• Support US REMS and ex-US Risk Management Program operational data and reporting requirements

• Support for active monitoring of products that require risk management programs

• Categorize REMS and ex-US Risk Management Program required reports in the REMS Strategy & Operations dashboard

• Track and trend categories of REMS and ex-US Risk Management Program and vendor required reports

• Assist with reconciliation activities performed for US REMS and ex-US Risk Management Programs

Experience with ARGUS/ARISg), MedDRA and WHO drug dictionary

Understand and ensure compliance and risk management requirements are met.

2+ year of financial industry experience

4+ years of Quality Assurance experience

2+ years of experience with Cloud technologies: AWS, PCF, PKS, Kubernetes, OpenShift, Linux, Azure, Windows, VMware

2+ years of experience in Automation and Continuous Integration-Continuous Development (CI-CD) of Full Circle applications

Experience with Agile Scrum (Daily Standup, Sprint Planning and Sprint Retrospective meetings) and Kanban

Expert knowledge and proven track record of REMS management and operations

Recent Pharmaceutical industry experience with patient services and/or vendor management

Oversight and management of Risk Evaluation and Mitigation Strategies (REMS) day-to-day activities

Liaise with specialty pharmacies to ensure that all REMS requirements and processes are managed and maintained

Manage day-to-day activities of Risk Evaluation and Mitigation Strategies (REMS) program to maintain regulatory compliance

Assess and implement ongoing REMS process and service-related improvements to ensure continuity and patient satisfaction while fostering a positive prescriber experience

Experience in and having an in-depth of understanding of the theory and practice of quality management (e.g., ICH Q10 Quality Systems)

Co-create and implements submission and post approval safety related inspection readiness activities by using change management strategies principles.

Broad-ranging experience in the global environment of pharmaceutical/biotechnology area including significant time working on REMS programs and/or Pharmacovigilance related areas.

Experience in leading range of global Pharmacovigilance related project, process improvement activities and in managing/hosting regulatory inspections or third-party audits

Experience conducting and monitoring Quality operational activities for REMS programs.

Conduct Quality operational activities as identified by the REMS project.