- Managing pro-actively the activities of the local/ regional activities of the Clinical Quality Assurance in close collaboration with global Clinical Quality Assurance (GCQA) organization to ensure inspection readiness, a fit for purpose Clinical Quality Management System (QMS), use of Risk Based Approaches to measuring quality and compliance and implementing.
- Continuous Improvement Initiatives.
- Responsible for the following: Canada SDC /RCC, US SDC.
- Set up, maintenance, improvement of the regional Clinical Quality Management System
(e.g. SOPs and local audits/self-inspections) to assure compliance with GCP, applicable
regulatory requirements and company standards.
- Distribution of GOPs/SOPs related to studies with humans to all personnel involved in
- Provides training related to study activities and regulations.
- Internal Consultancy, guidance and support to Sandoz employees on quality and GCP
- Support of clinical teams regarding audit and inspection readiness.
- Ensures vendor Qualification and adequate vendor audit follow-up.
- Escalation of high risk GCP areas and issues (including inspection announcements) to
- Planning of annual internal audits/self-inspections on a local level.
- Host audits and inspections related to study and CQA activities of local site and
involvement in Global audits and Health authority inspections as needed.
- Interaction and cooperation with vendor QA personnel, e.g. reviews relevant vendor SOPs.
- Supports, manages and advices on implementation of corrective/preventive actions from audits and inspections, and reported non-compliance issues.
- Conducts audits of local vendors after being qualified /certified.
- Ensure transfer of lessons learned from audits, inspection and non-compliance issues to
Clinical Research staff
- Collaborate with other departments within the company which impact study activities,
- Participation in Clinical QA group activities, including interfaces with global CQA managers
- Meets timelines/due dates of corrective and preventative actions resulting from audit or Inspection observations
- Feedback of co-workers regarding responsiveness and support in terms of clinical and quality related issues.
- Meets timelines/due dates as set by the Quality Plan (Clinical portion).
- Bachelor’s Degree in pharmaceutical, medical, nursing, life science or equivalent.
- Practical experience in clinical research and/or human research activities.
- Broad knowledge of respective clinical research related regulations including GxPs as applicable.
- Languages: English fluent in speaking and writing (French is helpful).
- Practical, hands-on experience within clinical development area.
- Experience in clinical QA would be an asset.
- Experience in an international matrix organization would be an asset.
- Excellent intercultural communication and negotiation skills
- Team player
- Dedicated to quality
- Strong analytical and organizational skills
- Attention to details but with an ability to see the overall picture.
- Willingness to travel- approximately 30%.
About Tech USA:
Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.
At Tech USA we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Tech USA is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. TechUSA is an equal opportunity employer.