At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
The Local Compliance Manager is responsible for performing activities within Canada that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global Standard Operating Procedures (SOPs), policies, local process and procedures and Health Care Compliance (HCC) for Phase 1-4 clinical trials across multiple therapeutic area(s). You will report to the local R&D/GCO Head with a dotted line reporting to the Regional Compliance Leader.
Key Responsibilities:
Oversee quality and compliance activities related to the conduct of clinical trials managed by the GCO Canada team including identification of risk at the country level, assessment of root causes and developing and/or recommending mitigation/remediation actions
Monitor progress and confirm effectiveness of remediation plans, perform special investigations and plan, prepare, conduct and report compliance assessments to ensure risk signals are addressed in a timely manner
Perform the following risk-based activities: On-Site Compliance Monitoring Visits and key study file reviews
Conduct Quarterly Quality Reviews with R&D/GCO Canada Head to address compliance issues and risk signals for the country
Collaborate with local and central business partners to facilitate Health Authority inspections and internal audits as needed.
Collaborate with local and central business partners for timely root cause analysis and CAPA (Corrective and Preventative Action) creation and implementation; be a CAPA Champion Support Lead for GCO Canada.
Initiate and lead continuous improvement initiatives that show demonstrable impact to the business and compliance processes
Develop and manage local procedural documents as required
Provide local support and advice regarding SOPs, system and GCP questions.
Support onboarding of new hires and planning/conducting of local workshops to support quality management, compliance awareness, lessons learned or the rollout of new initiatives
Perform impact assessments of new/revised local regulations, guidance and standards
Support Local Operating Company (LOC) Management Review in collaboration with LOC Business Quality partners
Support local supplier/vendor assessments
May directly or indirectly lead or supervise a compliance specialist
Qualifications
Minimum Bachelor of Science (B.Sc.), R.N., or equivalent degree in Biological Sciences
A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 3 years of compliance or quality assurance experience within clinical Research & Development
Excellent knowledge of drug development, clinical research operations, Health Canada Regulations and ICH-GCP
Experience in the conduct of audits (of clinical investigative sites, systems, vendors) and health authority inspections
Demonstrated skills in leadership, effective communication, and negotiation with various internal and external partners
Ability to translate data into information and strategies into executable action plans improving the business
Ability to independently plan, organize, coordinate, manage and execute assigned tasks in a fast paced and constantly evolving environment; demonstrated problem-solving skills
Excellent organizational skills and the ability to collaborate and handle multiple priorities
An asset if bilingual (English and French)
Willing and able to travel (domestic and international) up to 15% of the time.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
Primary Location
Canada-
Other Locations
North America-Canada-Quebec, North America-Canada-Ontario-Toronto
Organization
Janssen Inc. (7710)
Job Function
Quality
Requisition ID
2105936683W
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