Your new company

A world’s leading biotechnology company is looking for a Compliance Manager to join their team in Cambridge. Their main focus is to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Your new role

The role of the GXP Compliance Manager is to support the provision of proactive GCP compliance oversight and guidance to functional areas and stakeholder groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GCP Compliance.

This includes:
• Entering and updating records in RDCS based on investigation and exception meetings and tracking through to closure
• Supporting GCF Level 6 investigation lead in RCA & effectiveness verification activities of CAPAs
• Collating and verifying objective evidence for inspection & audit-driven CAPAs
• Assessing quality and accuracy of data in RDCS and reporting on RDCS status, progress and activities, as required based on regulations and guidance from GCF Level 6
• Data entry into the risk assessment tool (using risk assessment methodology)
• Support Safety, Global Development and Global Research teams in GCP inspection readiness and inspection management activities
• Support R&D Compliance on governance bodies in the clinical development, Pharmacovigilance and/or research area
• Support the GCP compliance team as needed with functional activities including exception management, inspection readiness, administration of compliance committees
• Maintain knowledge of current regulatory and compliance practices/issues
• Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key stakeholders
What you'll need to succeed

Experience
• Years of experience in biopharmaceutical industry
• Years of experience in GCP compliance
• Experience in exception management (include RCA) in a GCP setting
• Experience supporting regulatory authority inspections of GCP (e.g.clinical research, Pharmacovigilance) activities
• Participation in process improvement initiatives

Knowledge
• Knowledge of global GCP regulations
• Knowledge of regulatory authority inspection processes
• General knowledge GCP processes and operations in the bio-pharmaceutical industry
• Understanding of audit/compliance program design

Preferred Requirements
• GCP Quality Assurance Qualification/Certification (recommended)

Competencies
• Disciplinary knowledge; leverages business acumen and subject matter expertise
• Understanding of company goals and competitor practices
• Understanding of company business priorities, strategy and direction
• Knowledge of areas addressed by the GCP Compliance function
• Knowledge of R&D function and business principles
• Applies analytical skills to evaluate and interpret compliance situations (and viable solutions) using multiple sources of information, including qualitative, quantitative and trend data
• Manages multiple assignments
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #4254915