Local Compliance Specialist

We are looking for a clinical research professional with a passion for quality. The Compliance Specialist will be responsible for performing activities that ensure we conduct clinical trials to the required legal and quality standards. You can be based at home or in the office.

This exciting role includes performance of QC checks, audit and inspection support (preparation and responses), quality issue management (root cause analysis and CAPA development) including UK serious breach, identification and mitigation of risk, management of local SOPs, delivery of training on processes, regulations and quality, oversight of local vendors, and provision of a GCP Helpdesk service.

The role will work closely with UK Local Trial Managers and Site Managers (CRAs) to support inspection readiness across our clinical trial portfolio. The role also requires collaboration across other local and global functions., Quality and Compliance Oversight Activities

• Monitor compliance risk and ensure mitigation/remediation actions are defined following effective root cause assessment. Supervise progress and confirm efficiency of remediation plans,


• Perform and report QC checks and compliance assessments such as On-Site Compliance Monitoring Visits, reviews of Trial Master File, planning and execution of local QC checks, support local and central study teams in root cause analysis of significant observations


• Collaborate with business partners to facilitate (local) regulatory inspections and site/office audits


• Collaborate with local and central business partners in timely CAPA setting and implementation.


• Develop and manage local procedural documents/SOPs


• Coordinate local supplier assessments


Local Onboarding and Consultation

• Support onboarding of new hires


• Support and deliver local training on quality related topics


• Provide advice to the local team on process, system, and GCP-related questions


Local regulatory intelligence

• Maintain knowledge of the UK clinical research regulations and perform impact assessments of new/revised local regulations and guidance
  
  You should be flexible and be able to work independently. We are seeking to hire a good communicator, problem solver, quick learner, collaborator, and great teammate.


You will be part of a hard-working and committed local compliance team who provide quality leadership across all therapeutic areas and phases of in-house trials in the UK.

This role will suit someone with broad clinical research experience, working knowledge of GCP and the UK regulatory environment, and a dedication to quality., BSc (or equivalent) and 8 years relevant experience, predominantly in the UK. A minimum of 5 years of previous Pharma/CRO Industry experience is preferred, with GxP experience within clinical research and development (e.g., Site Manager (CRA)/Local Trial Manager roles) and/or quality assurance.

Related Experience:

• Knowledge of the overall drug development process


• Developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)


• Experience in audit and/or inspection process, and systems and vendors, is an asset


• Conflict resolution/management and negotiation skills


• Ability to independently plan, prioritise, coordinate, lead and complete assigned tasks


• Solid understanding of MHRA and HRA regulations and guidelines for clinical trials


General Skills:

• Problem solver


• Collaborator


• Highly committed to quality and compliance


• Flexible and persistent


• Good issue resolution skills


• Good written, oral communication, interpersonal skills, diplomacy, and presentation skills
  
  J&J Family of Companies Local Compliance Specialist in England, United Kingdom, At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.