Quality Assurance Manager- Clinical Research
Company: Kelly Services
Location: Toronto, ON
Key Rsponsibilities:
 Develops, directs and implements Quality Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.
 Responsible for:
 Organizing and managing Client Audits and Regulatory Inspections.
 Providing SOPs training to QA staff.
 Managing both Internal (Study Specific Audits, Facility Based Audit) and External Audits (Vendor audits) as per Company Standards.
 The oversight of Quality Assurance activities of external clinical trial sites during various phases of a clinical research study (as applicable).
 Coordinate and respond to Regulatory queries, deficiency letters, and/or to inspection and Audit observations.
 Assist in coordinating staff compliance training when appropriate.
 Ensure that Clinical studies are conducted in compliance with study protocols, GCP, GLP and federal guidelines, as well as ensure that client requirements fall within these guidelines.
 Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.
 Stays current with Quality Assurance and regulatory trends likely to impact the company: develops and implements recommendations regarding actions necessary to assure ongoing compliance.
 Actively participate in the Protocol Review Committee, Project Monitoring Meetings and the Management Committee.
 Manage the budget of the QA department.
 Coordinate GLP/GCP training.
 Provide feed back to the management and head Corporate QA regarding any Quality issues received internally and from the sponsors, visitors or Regulators.
 Evaluate and assess the process of any new development programs related to Quality Systems prior to seeking the services provided by external vendors or service providers.
 Provide leadership support and mentoring to the Quality Assurance team, including performance management, training, safety and supporting the annual performance appraisal process.
Position Requirements:
 Minimum B.Sc. degree in a scientific discipline or equivalent
 Minimum 5 years experience in a management or supervisory role in a CRO, and biotechnology industry in the areas of quality assurance and regulatory compliance.
 Must have Knowledge on Electronic Records, Electronic Signatures (21 CFR Part 11)
 Must have knowledge of Phase I, II & Generics
 Must have excellent knowledge of Health Canada, FDA & EMA regulatory requirements pertaining to Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and ICH Guidance Documents is a must.
 Excellent leadership, organizational and time management skills, with the ability to multi-task
 Excellent communication skills and high proficiency with the English language

If you have the skills and experience required for this position, please forward your resume to: E-mail: wendy.curtis@kellyservices.com