- Entry level
- No Education
- Salary to negotiate
Janssen Pharmaceutical, Companies of Johnson & Johnson is currently hiring a Manager, Process Excellence and Research Compliance located in Toronto, ON. This is a 1-year contract.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in hematology, oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases and women’s health. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
As the Manager, Process Excellence and Research Compliance you will be responsible for the development, oversight and maintenance of a quality system within Medical Affairs to ensure compliance to J&J Policies and Global/Local Regulatory requirements, establishing and ensuring that quality targets are achieved in support of Medical Affairs goals. You will also participate and provide compliance support and guidance to assigned cross-functional workgroups within RD Q&C, Global Medical Affairs, and Business Quality.
Your key responsibilities:
Establish Medical Affairs quality/compliance priorities, including coordination of internal audits, external regulatory inspections, procedural document review schedule, and quality improvement initiatives
Establish and oversee the resource model for Process Excellence and Research Compliance, including FTEs and Vendor support model; provides line management, coaching, development and leadership for direct reports and contingent workers
Manages inspection preparation activities, provides leadership during audit conduct and supports business partners during health authority inspections and internal audits as appropriate. Leads efforts in establishing appropriate corrective/preventative actions with respect to inspection/audit findings and correspondence with audit team/inspectors
Manage the development and implementation of procedures that ensure the business' quality standards, GCP process/oversight, and Pharmacovigilance obligations are met
Drive Quality and Compliance productivity, strategy optimization, process improvements and efficiencies in the development and implementation of processes and procedures that ensure the business' quality standards are met and key business questions are answered
Work with cross functional and global R&D quality and compliance leadership to develop, evaluate, and implement action plans which maintain or improve research quality
Analyze existing business processes to evaluate gaps, identify metrics/reporting opportunities, process improvements, and recommend business solutions aligned with our business’ strategy
Oversee the controlled document review cycle for Medical Affairs Standard Operating Procedures (SOPs)
Establish and oversee innovative solutions to process improvements, quality oversight and distilling of regulatory and J&J requirements
Maintain oversight of research-related technology systems, including J&J Activity Repository (JJAR) in partnership with Drug Safety & Surveillance team, Clinical Trial Management System (CTMS), Program Charter and Pubshare for Publication tracking, and the Research Concept Approval Process (RECAP)
Establish and oversee metrics and reporting for research and RWE key business questions and quality related triggers to support study concepts, operations (supporting GCDO), post-study summary reports and publications
Successful completion of a BSc. degree is required
Experience should include at least 5 years in pharmaceutical industry and/or a minimum of 3 years of clinical trial and/or quality related experience is required
Extensive knowledge and experience with regulatory compliance and clinical studies is an asset
Strong people management or leadership skills, either directly managing a team or proven leadership of cross-functional project team members is required
Excellent understanding of process, training in process excellence is an asset
Experience in continuous improvement and or quality improvement processes is an asset
Strong project management skills
Strong ability to negotiate and influence key stakeholders (internal & external)
Proficient in Document Management Systems is an asset
Demonstrated sound judgment in dealing with risk on compliance matters
Diversity and inclusion
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.